Intuitive Surgical (ISRG) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-31 10-K against the 2023-12-31 one, compared heading by heading and sentence by sentence.
Item 1A210 rewritten142 added116 removed614 unchanged
All filing items1,269 rewritten546 added449 removed2,685 unchanged
Summary
counted, not written
- Item 1A lists 46 risk factor headings: 2 new, 11 reworded and 33 unchanged since FY2023. 2 headings from FY2023 no longer appear.
- Sentence by sentence, 546 added, 449 removed, 1,269 rewritten and 2,685 unchanged across 19 items that differ.
New Item 1A headings (2)
- WE OFFER USAGE-BASED ARRANGEMENTS, INCLUDING ALTERNATIVE CAPITAL ACQUISITION APPROACHES; AS A RESULT, WE ARE EXPOSED TO AN INCREASED RISK OF LOSSES OF REVENUE AND INCREASED CREDIT RISK, WHICH COULD ADVERSELY AFFECT OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS.
- OUR BUSINESS IS SUBJECT TO COMPLEX AND EVOLVING LAWS AND REGULATIONS REGARDING DATA PRIVACY, DATA PROTECTION, ARTIFICIAL INTELLIGENCE, AND RESPONSIBLE USE OF DATA.AI
Removed Item 1A headings (2)
- WE OFFER ALTERNATIVE CAPITAL ACQUISITION APPROACHES AND, AS A RESULT, WE ARE EXPOSED TO THE CREDIT RISK OF SOME OF OUR CUSTOMERS AND THE RISK OF LOSSES OF REVENUE, WHICH COULD RESULT IN MATERIAL LOSSES.
- OUR BUSINESS IS SUBJECT TO COMPLEX AND EVOLVING LAWS AND REGULATIONS REGARDING PRIVACY, DATA PROTECTION, AND OTHER MATTERS RELATING TO INFORMATION COLLECTION.
Reworded Item 1A headings (11)
- WE EXPERIENCE LONG AND VARIABLE
[removed: CAPITAL SALES][added: CONTRACTING] CYCLES AND SEASONALITY IN OUR BUSINESS, WHICH MAY CAUSE FLUCTUATIONS IN OUR FINANCIAL RESULTS. - THIRD PARTIES MAY OFFER TO SELL
[removed: TO OUR CUSTOMERS]REMANUFACTURED[removed: AND/OR][added: OR] UNAUTHORIZED INSTRUMENTS AND ACCESSORIES[removed: OR]TO [added: OUR CUSTOMERS OR PROVIDE UNAUTHORIZED] SERVICE [added: ON] OUR SYSTEMS, WHICH COULD[removed: NEGATIVELY][added: ADVERSELY] IMPACT SAFETY, OUR FINANCIAL RESULTS, AND OUR REPUTATION. - ONGOING AND
[removed: POTENTIAL]FUTURE GLOBAL CONFLICTS COULD ADVERSELY AFFECT OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS. - INCORPORATING ARTIFICIAL INTELLIGENCE [added: TECHNOLOGIES] INTO OUR PRODUCTS, SERVICES, AND OPERATIONS MAY RESULT IN LEGAL AND REGULATORY RISKS OR
[removed: REPUTATIONAL HARM OR]HAVE OTHER ADVERSE CONSEQUENCES TO OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS. [removed: CONTINUED]CONSOLIDATION IN THE HEALTHCARE INDUSTRY COULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS.- IF OUR MANUFACTURING FACILITIES DO NOT CONTINUE TO MEET FEDERAL, STATE, OR OTHER MANUFACTURING [added: REGULATIONS AND] STANDARDS, WE MAY BE REQUIRED TO TEMPORARILY CEASE ALL OR PART OF OUR MANUFACTURING OPERATIONS, IMPORT/EXPORT OF OUR PRODUCTS, AND/OR RECALL SOME PRODUCTS, WHICH
[removed: WOULD][added: COULD] RESULT IN SIGNIFICANT PRODUCT DELIVERY DELAYS AND LOST REVENUE. - OUR PRODUCTS ARE SUBJECT TO INTERNATIONAL REGULATORY PROCESSES AND APPROVAL OR CERTIFICATION REQUIREMENTS. IF WE DO NOT OBTAIN AND MAINTAIN THE NECESSARY
[removed: INTERNATIONAL]REGULATORY[removed: APPROVALS OR CERTIFICATIONS,][added: REQUIREMENTS,] WE WILL NOT BE ABLE TO SELL OUR PRODUCTS IN OTHER COUNTRIES. - CHANGES IN HEALTHCARE LEGISLATION AND POLICY MAY HAVE
[removed: A MATERIAL][added: AN] ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS. - IF HOSPITALS AND OTHER
[removed: SURGERY][added: SURGICAL] FACILITIES DO NOT CONTINUE TO MEET FEDERAL, STATE, OR OTHER REGULATORY STANDARDS, THEY MAY BE REQUIRED TO TEMPORARILY CEASE ALL OR PART OF THEIR SYSTEM UTILIZATION. - OUR PRODUCTS [added: MAY] RELY ON LICENSES FROM THIRD PARTIES, WHICH MAY NOT BE AVAILABLE TO US ON COMMERCIALLY REASONABLE TERMS OR AT ALL. IF WE LOSE ACCESS TO THESE TECHNOLOGIES, OUR REVENUES COULD DECLINE.
- OUR FUTURE OPERATING RESULTS MAY BE BELOW
[removed: SECURITIES ANALYSTS’ OR INVESTORS’]EXPECTATIONS, WHICH COULD CAUSE OUR STOCK PRICE TO DECLINE.
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
210 rewritten, 142 added, 116 removed, 614 unchanged
In addition, the global economic environment [removed: and additional or unforeseen effects from COVID-19] [added: may] amplify many of these risks.
Technological advances could make such [removed: treatments] [added: treatment options] more effective or less expensive than using our products, which could render our products obsolete or unmarketable.
[removed: Studies] [added: Also, studies] could be published that show that other treatment options are more beneficial and/or cost-effective than robotic-assisted medical procedures.
For example, in 2023, certain drugs initially approved for use in diabetes patients gained market acceptance for use in weight loss [added: treatment] following FDA approvals for weight loss indications.
The availability and effectiveness of weight loss drugs have [removed: adversely impacted] [added: reduced the number of bariatric procedures performed, including those bariatric procedures performed using] our da Vinci surgical [removed: system bariatric procedures by causing] [added: system, as] some patients [removed: to] reconsider the surgical [added: treatment] option.
At this time, it is difficult to predict the long-term market impact of these drugs, including their long-term efficacy [added: as weight loss drugs] and potential drawbacks.
We cannot be certain that [removed: physicians] [added: physicians, or their patients,] will [removed: use] [added: choose] our products to replace or supplement established [removed: treatments] [added: treatment options] or that our products will continue to be competitive with current or future technologies.
Companies [added: that] have introduced products in the field of [removed: robotic] [added: robotic-assisted] medical [removed: procedures] [added: procedures,] or have made explicit statements about their efforts to enter the [removed: field including,] [added: field, include,] but [added: are] not limited to, the [removed: following companies: Asensus Surgical, Inc.;] [added: following:] Beijing Surgerii Robotics Company Limited; CMR Surgical Ltd.; [added: Distalmotion SA; Harbin Sizhe Rui Intelligent Medical Equipment Co., Ltd.;] Johnson & Johnson; [added: Karl Storz SE & Co. KG;] Medicaroid Corporation; Medtronic plc; meerecompany Inc.; Noah Medical; Shandong Weigao Group Medical Polymer Company Ltd.; Shanghai Microport Medbot (Group) Co., Ltd.; [removed: and] Shenzhen Edge Medical Co., [removed: Ltd.] [added: Ltd.; and SS Innovations International, Inc.] Other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.
Our revenues may be reduced due to pricing pressure [removed: or eliminated] if our competitors develop and market products that are more effective or less expensive than our products.
If we are unable to compete successfully with any third-party service providers, our revenues may [removed: suffer.][added: suffer, which could have a material adverse effect on our business, financial condition, or result of operations.]
Macroeconomic conditions, such as [removed: high] inflationary pressure, changes to monetary policy, [removed: high] [added: elevated] interest rates, volatile currency exchange rates, credit and sovereign debt concerns, concerns about slowed growth in China and other OUS markets, decreasing consumer confidence and spending, including capital spending, [removed: concerns about] the [removed: stability and liquidity of certain financial institutions, the] introduction of or changes in tariffs or trade barriers, and global or local recessions can adversely impact demand for our products, which could negatively impact our business, financial condition, or results of operations.
Recent macroeconomic conditions have been adversely impacted by geopolitical instability and military hostilities in multiple geographies (including the conflict between [removed: Ukraine and] Russia and [added: Ukraine and conflicts in] the [removed: conflict between] [added: Middle East, including] Israel and [removed: Hamas),] [added: Iran),] monetary and financial uncertainties, and the COVID-19 pandemic.
The results of these macroeconomic conditions, and the actions taken by governments, central banks, companies, and consumers in response, have [added: previously] resulted in, and may [removed: continue to] [added: again in the future] result in, higher inflation in the U.S. and globally, which [removed: is likely,] [added: could,] in turn, [removed: to] lead to an increase in costs and may cause changes in fiscal and monetary policy, including additional increases in [added: interest rates.]
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
For example, [removed: on March 10,] [added: in] 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the U.S. Federal Deposit Insurance Corporation (“FDIC”) as receiver.
Furthermore, hospitals and distributors may choose to postpone or reduce spending due to financial difficulties or difficulties in obtaining credit to finance purchases of our products due to [removed: increased] [added: elevated] interest rates and restraints on credit.
Hospitals and distributors may also be adversely affected by [removed: the] liquidity concerns in the broader financial services industry, as described above, that could result in delayed access or loss of access to uninsured deposits or loss of their ability to draw on existing credit facilities involving a troubled or failed financial institution.
[removed: Hospitals, in particular,] [added: Certain hospitals] are [removed: experiencing] [added: experiencing,] and may continue to [removed: experience] [added: experience,] financial and operational pressures as a result of staffing shortages, the supply chain environment, [added: a decrease in government funding in healthcare,] and [removed: high] [added: elevated] inflation, which could impact their ability to access capital markets and other funding sources, increase the cost of funding, or impede their ability to comply with debt covenants, all of which could impede their ability to provide patient care, defer elective surgeries, and impact their profitability.
[removed: If a recession] occurs, economies weaken, or inflationary trends continue, our business and [removed: operating] results [added: of operations] could be materially adversely affected.
[removed: Also, we have,] [added: We have experienced,] and may continue [removed: to, experience] [added: to experience,] supply chain constraints due to the current supply chain environment, including difficulties obtaining a sufficient supply of component materials used in our products.
If interest rates [removed: continue to rise,] [added: remain elevated,] access to credit may become more difficult, which may result in the insolvency of key suppliers, including single-source suppliers, which would exacerbate supply chain challenges.
Revenue from OUS markets accounted for approximately [removed: 34%,] 33%, [added: 34%,] and 33% of our revenue for the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021,] [added: 2022,] respectively.
- protectionist laws, policies, and business practices [added: and nationalistic campaigns] that favor local competitors or lead [removed: to] non-U.S. customers [removed: favoring] [added: to favor] domestic technology [removed: solutions,] [added: solutions over imports,] which could slow our [removed: growth] [added: growth, increase our costs, or make our products less competitive] in OUS markets;
- [added: compliance with] anti-corruption laws, such as the U.S. Foreign Corrupt Practices Act (“FCPA”), [added: UK Bribery Act of 2010 (“UK Bribery Act”),] and other local laws prohibiting corrupt payments to government officials;
- [added: adherence to] antitrust and anti-competition laws;
[removed: For example, in] [added: In] Israel, we have certain research and development operations primarily related to digital products.
Depending on the length and extent of [added: conflicts in] the [removed: conflict between] [added: Middle East, including] Israel and [removed: Hamas,] [added: Iran,] there may be adverse impacts to certain research and development timelines.
[removed: Also, we] [added: We] have increased, and will continue to increase, our operations in China.
[removed: We believe that these regulations do not materially adversely impact our business at this time but] [added: However, we] cannot predict the impact that additional regulatory changes may have on our business in the future.
[removed: Additionally,] [added: For example,] in July 2023, the Chinese government launched a [removed: one-year anti-corruption] campaign targeting the healthcare sector.
[removed: Currently, the] [added: The] extent [removed: of the] [added: and] impact of this [removed: anti-corruption] campaign on our business remains uncertain.
[removed: Following] [added: In the UK, following] a national referendum and enactment of legislation by the [removed: government of the UK,] [added: government,] the UK formally withdrew from the EU and ratified a trade and cooperation agreement governing its relationship with the EU.
[removed: The] [added: Pending such reform of the UK regulatory framework, the] Government has confirmed that general medical devices compliant with the EU Medical Devices Directive with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2028.
[removed: In addition, the] [added: The] U.S. federal government has made changes to the U.S. trade policy, including entering into a successor to the North American Free Trade Agreement (“NAFTA”), known as the United States-Mexico-Canada Agreement (“USMCA”), effective as of July 1, 2020.
In addition, the U.S. federal government has [removed: implemented, or is considering the imposition of,] [added: implemented] tariffs on certain foreign [added: goods and may implement additional tariffs on foreign] goods.
[removed: Furthermore, in] [added: In] certain markets, our OUS sales are denominated in U.S. dollars.
If we are unable to meet and manage these [removed: risks,] [added: risks noted above,] our OUS operations may not be successful, which would limit the growth of our business and could have a material adverse effect on our business, financial condition, or result of operations.
For example, product liability claims have been brought against us by, or on behalf of, individuals alleging that they have sustained personal injuries and/or death as [removed: a result of purported product defects, the alleged failure to warn, and/or the alleged inadequate training by us of physicians regarding the use of the da Vinci surgical system.]
[removed: Current product] [added: Product] liability claims have resulted in negative publicity regarding our Company, and [removed: these and any other] [added: ongoing or future] product liability or negligence claims or product recalls [removed: also] could [added: also] harm our reputation.
We cannot determine whether our existing business insurance program would be sufficient to cover the costs or potential losses related to [removed: these] [added: our] lawsuits and [added: legal] proceedings or otherwise be excluded under the terms of any insurance policy.
Additionally, we currently face, or anticipate facing, competition from companies with products used in open or MIS surgeries, including laparoscopy and alternative multi-port, single-port, or endoluminal systems.
We also compete with companies providing other therapeutic approaches for addressing target clinical conditions, as well as companies developing diagnostic solutions that could serve as alternatives to current or planned Intuitive offerings.
Additionally, we expect increasing competition within China for robotic-assisted surgical systems.
- changes in tariffs, trade barriers, and regulatory requirements, such as the enactment of tariffs on goods imported into the U.S. including, but not limited to, the proposed tariff on goods imported from Mexico where we manufacture a significant majority of our instruments and accessories that we sell;
Additionally, our joint venture works with and relies on a number of dealers, distributors, and other third parties to commercialize and deliver our products.
Based on our current understanding of these regulations, they do not materially adversely impact our business at this time.
In China, we have seen increasing competition in the robotic-assisted surgical system industry from domestic companies as well as a broader central government focus on systematic governance.
This campaign has resulted in heightened scrutiny by medical institutions with respect to initiating tenders, with some tenders being canceled or delayed without a timeline.
In 2024, the effects of this campaign, combined with the competitive dynamics in China, contributed to fewer systems being placed in China than we anticipated.
Currently, the extent and impact of this campaign and the competitive dynamics in China on our business remains uncertain.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
On January 9, 2024, the MHRA published a roadmap setting out its plans and timelines towards the reform of the regulatory framework for medical devices in the UK.
Regulations implementing core elements of the new framework are intended to be in place by 2025.
For example, on January 20, 2025, the U.S. presidential administration re-confirmed its intention to impose a 25% tariff on imports from Mexico and Canada into the United States as early as February 1, 2025.
As we currently manufacture a significant majority of our instruments and accessories in Mexicali, Mexico, a 25% tariff on all imports from Mexico would increase the costs of our products manufactured in Mexico and adversely impact our gross profit.
The ultimate impact of any tariffs will depend on various factors, including if any tariffs are ultimately implemented, the timing of implementation, and the amount, scope, and nature of the tariffs.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
a result of purported product defects, the alleged failure to warn, and/or the alleged inadequate training by us of physicians regarding the use of the da Vinci surgical systems.
We are increasingly offering usage-based arrangements as part of our business model.
As a result, we are exposed to an increased risk of losses of revenue in any period where the usage decreases.
Moreover, our pricing is generally set based on the expected usage of the technology.
Therefore, if utilization of our technology falls short of the anticipated levels, we may not be able to recover the costs associated with the technology, which could adversely affect our business, financial condition, or results of operations.
Moreover, there is risk in forecasting future utilization of a system and, therefore, we may not set our usage-based rates high enough to maintain our gross profit margins.
If systems that are not fully depreciated are returned, we could also incur additional losses, as we may not be able to recover the remaining value of those returned assets, thereby negatively impacting our financial results.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Current supply chain constraints include difficulties in obtaining a sufficient supply of engineered raw materials and certain subcontract suppliers being operationally challenged to meet our production requirements.
Additionally, prices of materials for some components remain elevated from historical levels due to strong market demand or supply chain cost inflation.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
- changes in the mix of fixed payment or usage-based operating lease arrangements;
- fluctuations in foreign currency exchange rates;
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Cybersecurity breaches also remain a threat to our sustained supply continuity.
If a recession
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Cyberattacks and other security breaches or disruptions continue to increase in frequency, sophistication, and intensity and are becoming increasingly difficult to detect for periods of time, especially as they relate to attacks on third-party providers or their vendors.
Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Furthermore, as market competition intensifies, there is an increased risk that our current or emerging competitors may attempt to hire our key personnel, which could be achieved through offers of substantial financial incentives or strategic opportunities, aiming to capitalize on their knowledge to accelerate their own product development initiatives.
Additionally, we face or expect to face competition from companies that develop or have developed wristed, robotic-assisted, or computer-assisted medical systems and products.
interest rates.
- changes in tariffs, trade barriers, and regulatory requirements;
The efforts of this campaign largely aim to curb kickbacks and corruption among individuals who have exploited their positions within medical institutions.
As a result of this anti-corruption campaign, the medical institutions have heightened their scrutiny with respect to initiating tenders.
Therefore, some tenders were cancelled or delayed without an updated timeline.
In the third and fourth quarters of 2023, the effect of this anti-corruption campaign contributed to fewer systems being placed in China.
On June 26, 2022, the MHRA published its response to a 10-week consultation on the future regulation of medical devices in the UK.
Regulations implementing the new regime were originally scheduled to come into force in July 2023 but the MHRA has confirmed that it is aiming for the core aspects of the new regime to apply from July
2025.
Devices which have valid CE certification issued by EU notified bodies under the EU Medical Devices Regulation or Medical Devices Directive are subject to transitional arrangements.
Following these transitional periods, it is expected that all medical devices will require a UK Conformity Assessment mark.
Manufacturers may choose to use the UKCA mark on a voluntary basis prior to the regulations coming into force.
However, from July 2025, products that do not have existing and valid CE certification under the EU Medical Devices Directive or EU Medical Devices Regulation and are therefore not subject to the transitional arrangements will be required to carry the UKCA mark if they are to be sold into the market in Great Britain.
UKCA marking will not be recognized in the EU.
Difficulties remain in obtaining a sufficient supply of semiconductor and other component materials, and we expect such difficulties to persist in the foreseeable future.
Prices of such materials have also increased, and global supply has become constrained due to the increased demand for materials, including semiconductors, to support expansion of server and cloud networks as a greater proportion of the global population worked remotely, the introduction of 5G, and the continued electrification of vehicles.
We engage in activities to seek to mitigate such supply disruptions by, for example, increasing our communications with our suppliers and modifying our purchase order coverage and inventory levels.
Such global shortages in important components have resulted in, and will continue to cause, inflationary pressure in our supply chain, which would impact our profits and profit margin.
In addition, the introduction or announcement of new products or product
Companies providing robotic surgical technology,
To date, COVID-19 has had, and may continue to have, an adverse impact on our operations, our supply chains and distribution systems, and our expenses, including as a result of preventive and precautionary measures that we, other businesses, and governments have taken and may continue to take.
In addition, hospitals are experiencing staffing shortages and supply chain issues that could impact their ability to provide patient care.
Due to these impacts and measures, we have experienced, and may continue to experience, significant and unpredictable reductions in the demand for our products as healthcare customers divert medical resources and priorities towards the treatment of that disease.
Also, our customers have delayed, cancelled, or redirected and, in the future, may delay,
cancel, or redirect, planned capital expenditures in order to focus resources on COVID-19 or in response to economic disruption related to COVID-19.
For example, as a result of the global COVID-19 pandemic, in the first half of 2020, we experienced a significant decline in procedure volume in the U.S. and Western Europe, as healthcare systems diverted resources to meet the increasing demands of managing COVID-19.
In addition, U.S. and global public health bodies have, at times, recommended delaying elective surgeries during the COVID-19 pandemic, which may continue to negatively impact the usage of our products and the number of da Vinci procedures performed.
These delays in elective surgeries may create a patient backlog.
Also, as we are conducting IDE studies to support 510(k) submission for da Vinci platforms and for seeking new indications, we may experience delays in obtaining new product approvals, clearances from the FDA, or approvals or certifications from foreign authorities or notified bodies, or we may experience delays in recruiting patients in our ongoing and planned clinical studies.
As a result of the COVID-19 outbreak, we experienced significant business disruptions, including restrictions on our ability to travel as well as distribute and service our products, temporary closures of our facilities and the facilities of our suppliers and their contract manufacturers, and a reduction in access to our customers due to diverted resources and priorities and the business hours of hospitals, as governments institute prolonged shelter-in-place and/or self-quarantine mandates.
These unprecedented measures to slow the spread of the virus taken by local governments and healthcare authorities globally, including the deferral of elective medical procedures and social distancing measures, had, and may continue to have, a negative impact on our operations and financial results.
Furthermore, our future ways of working changes, including working from home, fully on-site, or in a hybrid fashion, may present additional risks, uncertainties, and costs that could affect our performance, including increased operational risk, uncertainty regarding office space needs, heightened vulnerability to cyberattacks due to remote work, potential reduced productivity, changes to our company culture, and increased costs to ensure our offices are safe and functional as hybrid offices that enable effective collaboration of both remote and in-person colleagues.
In addition, the COVID-19 pandemic adversely affected and may continue to adversely affect the economies and financial markets of many countries, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could curtail or delay spending by hospitals and affect demand for our products as well as increased risk of customer defaults or delays in payments.
Our customers may terminate or amend their agreements for the purchase, lease, or service of our products due to bankruptcy, lack of liquidity, lack of funding, operational failures, or other reasons.
COVID-19 and the current financial, economic, and capital markets environment, and future developments in these and other areas, present material uncertainty and risk with respect to our performance, financial condition, volume of business, or results of operations.
Outbreaks of other epidemic, pandemic, or contagious diseases, such as, historically, the Ebola virus, Middle East Respiratory Syndrome, Severe Acute Respiratory Syndrome, or the H1N1 virus, could also divert medical resources and priorities towards the treatment of that disease.
An outbreak of other contagious diseases could negatively affect hospital admission rates or disrupt our business similar to the impact of the COVID-19 pandemic highlighted above.
and help us produce our Consolidated Financial Statements.
The risk of a security breach or a disruption has generally increased in number, intensity, and sophistication.
An excerpt. Shown here: 40 of 210 rewritten, 40 of 142 added and 40 of 116 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2024 filing and the FY2023 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
342 rewritten, 120 added, 111 removed, 399 unchanged
Open surgery remains [removed: the predominant] [added: a prevalent] form of surgery and is used in almost every area of the body.
For over [removed: three] [added: four] decades, MIS has reduced trauma to patients by allowing selected surgeries to be performed through small ports rather than large incisions.
We [removed: also] provide a comprehensive suite of systems, learning, and services offerings.
[removed: Digitally-enabled] [added: Digitally enabled] for nearly three decades, these three offerings aim to decrease variability by providing dependable, consistent functionality and an integrated user experience.
Our learning category includes [removed: educational] [added: learning and enabling] technology, such as simulation and telepresence, as well as technical training programs and personalized peer-to-peer learning opportunities.
We have commercialized the following da Vinci surgical systems: the da Vinci standard surgical system in 1999, the da Vinci S surgical system in 2006, the da Vinci Si surgical system in 2009, [removed: and] the [removed: fourth generation] [added: fourth-generation] da Vinci Xi surgical system in [removed: 2014.][added: 2014, and the fifth-generation da Vinci 5 surgical system in 2024.]
We are in the early stages of launching our da Vinci SP surgical system, and we have an installed base of [removed: 177] [added: 273] da Vinci SP surgical systems as of December 31, [removed: 2023.][added: 2024.]
We have received FDA clearance for the da Vinci SP surgical system for [removed: urologic] [added: urologic, colorectal, general thoracoscopic,] and certain transoral [removed: procedures, and we have received regulatory clearance in South Korea, where the da Vinci SP surgical system may be used for a broad set of] procedures.
[removed: In September 2022, we received regulatory clearance for the] [added: The] da Vinci SP surgical system [added: has also received regulatory clearance] in Japan for the same set of procedures [removed: as can be performed on] [added: that are currently allowed with] the da Vinci Xi surgical system in Japan.
In January 2024, we obtained [removed: the] European certification in accordance with [removed: 2017/745] [added: the] EU MDR [removed: (Medical Devices Regulation)] for our da Vinci SP surgical system for use in endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.
We [removed: plan to commercialize] [added: are commercializing] the da Vinci SP surgical system in select major European countries [removed: throughout 2024] as part of a measured [removed: rollout strategy.][added: rollout.]
We plan to seek FDA clearances for additional indications for the da Vinci SP surgical system [added: and expand the system’s regulatory approvals (including for additional indications) in other OUS markets] over time.
We [removed: also] plan to seek [removed: clearances (including for] additional [removed: indications)] [added: clearances, approvals, and certifications for our Ion endoluminal system] in [removed: other] OUS markets over time.
[removed: If we obtain] [added: We are in] the [removed: required regulatory clearances, we plan] [added: midst of] a phased launch over several [removed: quarters after clearance,] [added: quarters,] giving us time to mature our supply and manufacturing processes for the new system.
We offer advanced instrumentation for the da Vinci [removed: X] [added: 5, da Vinci X,] and da Vinci Xi [removed: platforms,] [added: surgical systems,] including da Vinci [removed: Energy] [added: energy] and da Vinci [removed: Stapler] [added: stapler] products, to provide surgeons with sophisticated, computer-aided tools to precisely and efficiently interact with tissue.
The da Vinci [removed: X] [added: 5, da Vinci X,] and da Vinci Xi surgical systems [added: generally] share the same instruments, whereas the da Vinci Si surgical system uses instruments that are not [added: compatible with the da Vinci 5, da Vinci X, and da Vinci Xi systems.]
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
We [added: also] currently offer nine core instruments on our da Vinci SP surgical system.
We plan to expand [removed: the] [added: our] da Vinci SP instrument offering over time.
In 2019, [removed: the FDA cleared] [added: we commercialized] our Ion endoluminal system, which is a flexible, robotic-assisted, catheter-based platform that utilizes instruments and accessories for which the first cleared indication is minimally invasive biopsies in the lung.
Our Ion system extends our commercial offering beyond surgery into [removed: diagnostic] [added: diagnostic,] endoluminal procedures.
In March 2023, we obtained [removed: the] European certification in accordance with [removed: 2017/745] [added: the] EU MDR [removed: (Medical Devices Regulation)] for our Ion endoluminal [removed: system and, in September 2023, we received regulatory clearance for our Ion endoluminal system in South Korea.][added: system.]
The success of new product introductions depends on a number of factors including, but not limited to, pricing, competition, [added: geographic] market and consumer acceptance, the effective forecasting and management of product demand, inventory levels, the management of manufacturing and supply costs, and the risk that new products may have quality or other defects in the early stages of introduction.
[removed: Uncertainty] [added: Our future results of operations and liquidity could be materially adversely affected by uncertainty] surrounding macroeconomic and geopolitical factors in the U.S. and globally characterized by the supply chain environment, inflationary pressure, [removed: higher] [added: elevated] interest rates, [removed: instability in the global financial markets, significant] disruptions in the commodities’ markets as a result of the conflict between Russia and Ukraine and [added: conflicts in] the [removed: conflict between] [added: Middle East, including] Israel and [removed: Hamas, labor shortages,] [added: Iran,] and the introduction of or changes in tariffs or trade [removed: barriers may result in a recession, which could have a material adverse effect on our business.][added: barriers.]
With [removed: higher] [added: elevated] interest rates, access to credit [removed: may become] [added: is] more [removed: difficult] [added: difficult,] and any insolvency of certain suppliers, including sole- and single-sourced suppliers, may have heightened continuity risks.
We are actively engaged in activities [removed: to] [added: that] seek to mitigate the impact of any supply chain [added: risks and] disruptions on our operations.
[removed: A number of] [added: Some] hospitals continue to experience challenges with staffing and cost pressures that could affect their ability to provide patient [removed: care; however, the staffing challenges have shown signs of improvement during the second half of 2023, relative to the first half of 2023 and to the prior year.][added: care.]
Additionally, [added: certain] hospitals are facing significant financial pressure as supply chain constraints and inflation [removed: drive] [added: have driven] up operating [removed: costs, higher] [added: costs and elevated] interest rates [removed: make] [added: have made] access to credit more [removed: expensive, unrealized losses decrease available cash reserves, and fiscal stimulus programs enacted during the COVID-19 pandemic wind down.][added: expensive.]
[removed: Vinci procedures performed] [added: Any] or [added: all of these factors could negatively impact] the number of [removed: system placements] [added: da Vinci procedures performed or surgical systems placed] and have a material adverse effect on our business, financial condition, or results of [removed: operations resulting in the failure to achieve our anticipated financial results.][added: operations.]
In [added: the first fiscal quarter of] 2023, COVID-19 resurgences in China [removed: continued to] negatively [removed: impact] [added: impacted] our procedure volumes in [removed: January.][added: the region.]
[removed: During the remainder of 2023, we] [added: We] did not experience significant [added: procedure volume] disruptions [removed: from COVID-19.][added: due to COVID-19 outbreaks in any of our geographic markets during the remainder of 2023.]
We generate [added: up-front] revenue from the placement of da Vinci surgical [removed: systems, in] [added: systems through] sales or sales-type lease arrangements [removed: where] [added: and recurring] revenue [removed: is recognized up-front or in] [added: over time through] fixed-payment or usage-based operating lease [removed: arrangements where revenue is recognized over time.][added: arrangements.]
We [added: also] earn recurring revenue from the sales of instruments, accessories, and [removed: services, as well as revenue from operating leases.][added: services.]
The da Vinci surgical system generally sells for between $0.7 million and [removed: $2.5] [added: $3.1] million, depending on the model, configuration, and geography, and represents a significant capital equipment investment for our customers when purchased.
We generally earn between [removed: $700] [added: $800] and $3,600 of instruments and accessories revenue per surgical procedure performed, depending on the type and complexity of the specific procedures performed and the number and type of instruments used.
We typically enter into service contracts at the time systems are sold or leased at an annual fee between [removed: $80,000] [added: $100,000] and [removed: $200,000,] [added: $225,000,] depending on the configuration of the underlying system and the composition of the services offered under the contract.
We generate [added: up-front] revenue from the placement of Ion [removed: systems, in] [added: systems through] sales or sales-type lease arrangements [removed: where] [added: and recurring] revenue [removed: is recognized up-front or in] [added: over time through] fixed-payment or usage-based operating lease [removed: arrangements where revenue is][added: arrangements.]
The Ion [added: endoluminal] system generally sells for between $500,000 and [removed: $650,000.][added: $815,000.]
We typically enter into service contracts at the time systems are sold or leased at an annual fee between $55,000 and [removed: $65,000.][added: $80,000.]
Recurring revenue increased to [removed: $5.94] [added: $7.04] billion, or [removed: 83%] [added: 84%] of total revenue in [removed: 2023,] [added: 2024,] compared to [removed: $4.92] [added: $5.94] billion, or [removed: 79%] [added: 83%] of total revenue in [removed: 2022,] [added: 2023,] and [removed: $4.29] [added: $4.92] billion, or [removed: 75%] [added: 79%] of total revenue in [removed: 2021.][added: 2022.]
We have a global network of field service engineers and distributors through which we deliver a suite of services, including installation, repair, maintenance, around-the-clock technical support, and system monitoring.
We also offer customized analytics and consultation to hospitals for program optimization.
Additionally, the da Vinci SP surgical system has received regulatory clearance in South Korea for a broad set of procedures.
In August 2024, we obtained regulatory clearance in Taiwan for our da Vinci SP surgical system for use in endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, transanal total mesorectal excision, and breast surgical procedures.
In March 2024, we obtained FDA clearance for our da Vinci 5 surgical system, our next-generation multi-port robotic system, for use in all surgical specialties and procedures indicated for da Vinci Xi, except for cardiac and pediatric indications.
In October 2024, we obtained regulatory clearance in South Korea for the da Vinci 5 surgical system for use in urologic, general, gynecologic, thoracoscopic, thoracoscopically-assisted cardiotomy, and transoral otolaryngology surgical procedures.
We are in the early stages of launching da Vinci 5, and we have an installed base of 362 da Vinci 5 surgical systems as of December 31, 2024.
Additionally, we are in the regulatory process in Japan and Europe for da Vinci 5.
Additionally, we have introduced a unique set of force feedback instruments that are only compatible with our da Vinci 5 surgical system.
Our learning and enabling technology offerings facilitate access to education and training on our products.
Our enabling technologies include telepresence and Advanced Insights Suite (which includes Case Insights and Insights Engine), and our learning technology solutions include Intuitive Learning, SimNow, customized training models, remote case observations, and remote proctoring.
Our Ion endoluminal system has received FDA clearance, and OUS regulatory clearances include European certification in accordance with the EU MDR, regulatory clearance in South Korea, and NMPA regulatory clearance in China.
Supply chain constraints have generally improved to pre-COVID-19 pandemic levels, with some isolated residual stresses, particularly for engineered raw materials and at certain subcontract suppliers that are operationally challenged to meet our production requirements.
These isolated instances did not have a material impact during 2024.
Additionally, material and labor prices to produce some components remain elevated from historical levels due to market dynamics, demand mix, or general cost inflation within the supply chain.
Incidents of cybersecurity breaches, which have not significantly impacted our supply chain to date, also remain an active threat to sustained supply continuity.
Hospitals may also be adversely affected by the liquidity concerns as a result of the broader macroeconomic environment.
COVID-19 has had a negative impact on our procedure volumes during periods with COVID-19 outbreaks due to patient delays in both the diagnosis and treatment of diseases.
While such delays have negatively impacted our procedure volumes in periods with COVID-19 outbreaks, we believe that these delays have also resulted in increased procedure volumes during those periods following such outbreaks, due to the treatment of patients in backlogs that were created during the COVID-19 outbreak.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
However, as infections and hospitalization decreased, our procedure volumes recovered.
Instead, throughout 2023, we saw a positive impact on procedure volumes and believe that such positive impacts were partially attributable to patients who had deferred treatment returning for diagnosis and treatment.
During 2024, we did not experience noticeable procedure volume disruptions due to COVID-19.
We also believe that a large portion of the patients in the backlog that required treatment during the COVID-19 pandemic have now been treated.
Therefore, we believe that the impact of patient backlogs was less significant on procedure volumes in 2024 than what was experienced in 2023.
We also earn recurring revenue from the sales of instruments, accessories, and services.
We believe that the installed base, number of placements, and utilization of systems are useful to investors as metrics, because (1)
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
We generally set fixed-payment and usage-based
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Revenue for usage-based operating lease arrangements is recognized as the system is used to perform procedures.
Variable usage-based arrangements create better matching of reimbursements and cost for our customers.
They also reduce our customers’ overall risk and need for capital outlay.
However, because the number of procedures performed in any given period can vary significantly for many reasons, including but not limited to healthcare emergencies, alternative treatment options, and patient preferences, revenue recognized from these arrangements can be highly volatile.
Customers generally do not have the right to exit or terminate a fixed-payment lease without incurring a penalty.
However, because of the variability in revenue recognized for usage-based lease arrangements, including our customers’ ability to exit or cancel those arrangements prior to the end of the lease term, there is no guarantee that we will recuperate the cost of the leased system, which, in turn, could adversely impact our gross profit margins if utilization of those systems are different than our expectations.
For trade-in activities involving operating lease upgrades, depending on the timing and terms of the upgrade transaction, the amount of revenue generated on the initial and new lease arrangements may not, in the aggregate, generate the same amount of revenue that a traditional sale and trade-in transaction would.
Systems revenue increased 17% to $1.97 billion in 2024.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
In addition, historically, placements of our da Vinci surgical systems have tended to be heavier in the fourth quarter and lighter in the first quarter, as hospital budgets are reset.
Our services category assists and optimizes minimally invasive programs through readiness, on-demand support, consultation for minimally invasive program optimization, and hospitals customized analytics.
Within our integrated ecosystem, our focus is to decrease variability in surgery by offering actionable insights, with digital solutions, to take action with the potential to improve outcomes, personalize learning, and optimize efficiency.
We take a holistic approach, offering intelligent technology and systems designed to work together to make MIS intervention more available and applicable.
In addition, we have submitted regulatory filings in the U.S., Japan, and South Korea for our fifth-generation multi-port platform, da Vinci 5.
compatible with the da Vinci X or da Vinci Xi systems.
Training technologies include our Intuitive Simulation products, our Intuitive Telepresence remote case observation and telementoring tools, and our dual console for use in surgeon proctoring and collaborative surgery.
We plan to seek additional clearances, approvals, and certifications for the Ion endoluminal system in OUS markets over time.
Supply chain constraints continued to show improvement as 2023 progressed, relative to 2022, based on fewer market constraints.
Notably, supply of semiconductor materials rebounded, while certain residual stresses remain.
Additionally, prices of such materials remain elevated due to either market demand or production-related cost inflation.
Global shortages in important components have resulted in, and will continue to cause, inflationary cost pressure in our supply chain.
To date, these supply chain challenges have not materially impacted our results of operations or ability to deliver products and services to our customers.
However, supply constraints with certain materials, which may be unavoidable, could delay the timing of finished product deliveries, which could result in deferred or canceled procedures.
Additionally, if inflationary pressures in component costs persist, we may not be able to quickly or easily adjust pricing, reduce costs, or implement countermeasures.
Also, there is continued uncertainty surrounding the impact of any monetary policy changes taken by the U.S. Federal Reserve and other central banks to address the structural risks associated with inflation.
Fluctuations in labor availability globally, including labor shortages and staff burnout and attrition, could also impact our ability to hire and retain personnel critical to our manufacturing, logistics, and commercial operations.
We are also highly dependent on the principal members of our management and scientific staff.
The loss of critical members of our team, or our inability to attract and retain qualified personnel, could significantly harm our operations, business, and ability to compete.
Hospitals may also be adversely affected by the liquidity concerns in the broader financial services industry that could result in delayed access or loss of access to uninsured deposits or loss of their ability to draw on existing credit facilities involving a troubled or failed financial institution.
As a consequence of the financial pressures and decreased profitability, some hospitals have indicated that they are lowering their capital investment plans and tightening their operational budgets.
We believe that these factors have contributed to a softening in our U.S. capital pipeline, and we expect that demand for capital, particularly in the U.S., will continue to be impacted while macroeconomic conditions remain challenging.
In addition, as overall competition for medical technologies, including robotic-assisted devices and treatment options, progresses in various markets, we will likely experience longer selling cycles and pricing pressures.
Any or all of these factors could negatively impact the number of da
We maintain the majority of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits exceed insured limits.
Market conditions could impact the viability of these institutions.
To date, these market conditions and liquidity concerns have not impacted our results of operations.
However, in the event of the failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all.
Any inability to access or delay in accessing these funds could adversely affect our business and financial position.
In 2021, resurgences of the outbreak of a novel strain of coronavirus (COVID-19) affected da Vinci procedure volumes at various times throughout the year in most of the markets that we operate in.
After each resurgence, as COVID-19 cases and hospitalizations subsided, we saw procedure volumes recover.
In the U.S., the impact of high COVID-related hospitalization rates on procedure volumes was exacerbated by staffing shortages.
Although hospitals were better equipped to handle COVID patients as compared to the outset of the pandemic, COVID-19 resurgences challenged hospital resources and negatively impacted da Vinci procedure volumes.
In addition, delays in diagnosis and treatment of underlying conditions had a negative impact on da Vinci procedure volumes.
Volumes associated with benign procedures were generally impacted to a higher degree when COVID-19 cases and hospitalizations increased, reflecting the deferability of certain elective surgeries.
In early 2022, a resurgence of COVID-19 resulted in a significant increase in infections and hospitalization rates in the U.S. and certain countries in Europe, which, in turn, negatively impacted procedure volumes in January and February.
As infections and hospitalizations started to decrease in February in the U.S. and Europe, we saw a recovery of procedure volumes.
In March and during the second quarter of 2022, we also saw a resurgence in COVID-19 cases and increased hospitalizations and government interventions impacting parts of Asia, particularly China, which negatively impacted procedure volumes.
During the third quarter of 2022, we did not experience significant disruptions from COVID-19.
In the fourth quarter of 2022, we saw a resurgence in COVID-19 cases in China, which had a significant negative impact on our procedure volumes in the region.
However, in February and March, as infections and hospitalization started to decrease, we saw a recovery of procedure volumes.
An excerpt. Shown here: 40 of 342 rewritten, 40 of 120 added and 40 of 111 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2024 filing and the FY2023 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
7 rewritten, 0 added, 0 removed, 23 unchanged
To achieve this objective, we maintain a diversified portfolio of cash equivalents and short- and long-term investments in a variety of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, [added: high-quality] corporate notes and bonds, commercial paper, non-U.S. government agency securities, and [added: taxable and tax-exempt] municipal notes.
The weighted average duration of our portfolio as of December 31, [removed: 2023,] [added: 2024,] was approximately [removed: 0.8] [added: 1.3] years.
A hypothetical increase or decrease in interest rates by 25 basis points would have resulted in a decrease or increase in the fair value of our net investment position of approximately [removed: $14] [added: $28] million, respectively, as of December 31, [removed: 2023.][added: 2024.]
For the year ended December 31, [removed: 2023,] [added: 2024,] sales denominated in foreign currencies were approximately [removed: 25%] [added: 24%] of total revenue.
For the year ended December 31, [removed: 2023,] [added: 2024,] our revenue would have decreased by approximately [removed: $121] [added: $118] million if the U.S. dollar exchange rate strengthened by 10%.
A 10% strengthening of the U.S. dollar exchange rate against all currencies to which we have exposure, after considering foreign currency hedges and offsetting positions as of December 31, [removed: 2023,] [added: 2024,] would have resulted in an approximately [removed: $1] [added: $12] million increase in the carrying amounts of those net assets.
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
Item 1. BUSINESS
130 rewritten, 81 added, 63 removed, 489 unchanged
Intuitive®, Intuitive Surgical*®*, da Vinci®, da Vinci S®, da Vinci Si®, da Vinci X®, da Vinci Xi®, da Vinci 5™, da Vinci SP®, EndoWrist®, Firefly®, [added: Flexision®,] Intuitive 3D Models™, Intuitive Hub™, Ion®, My Intuitive™, OnSite®, SimNow®, SureForm®, and SynchroSeal® are trademarks or registered trademarks of the Company.
As part of Intuitive’s mission, we believe [added: that] minimally invasive care is life-enhancing care.
[removed: Through] [added: By combining] ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
We envision a future of care that is less invasive and profoundly better, where diseases are identified [removed: earlier] [added: early] and treated quickly so patients can get back to what matters most.
[removed: This connected] [added: We do so by providing a comprehensive] ecosystem [added: that] includes [added: robotic-assisted] systems, instruments and accessories, [added: customer] learning, and [added: support] services [added: all] connected by a digital portfolio that enables actionable [removed: digital] insights across the care [removed: continuum and provides enhanced capabilities, intraoperative guidance, decision support, and a personalized learning journey, all with the goal to help improve outcomes and efficiency.][added: continuum.]
While surgery and acute interventions have improved significantly in the past [added: few] decades, there remains a significant need [removed: for better outcomes and decreased variability of these outcomes] [added: to improve] across [removed: care teams.][added: all aspects of the Quintuple Aim.]
[removed: The current] [added: Globally,] healthcare [removed: environment continues] [added: systems continue] to [removed: stress] [added: be stressed and lacking in] critical resources, including the professionals who staff care teams.
At the same time, [added: healthcare providers, payers, and] governments strain to cover the healthcare needs of their populations and demand lower total [removed: costs] [added: cost] per patient to treat disease.
In the face of these challenges, we [added: continue to] believe [added: that we are well-positioned to synthesize] scientific and technological advances in biology, computing, imaging, algorithms, and robotics [removed: may offer new methods] to [removed: solve continued] [added: deliver meaningful] and [removed: difficult problems.][added: measurable value to all of our stakeholders.]
[removed: Finally,] [added: Fourth,] we [removed: seek] [added: aim] to [added: help] lower the total cost [removed: to treat] [added: of care] per patient episode when compared with existing treatment alternatives, providing a return on investment for hospitals and healthcare systems and value for payers.
Advanced robotic systems provide precise, powerful [removed: systems] [added: platforms] with high-performance vision, extending the care team’s capabilities to enhance minimally invasive care.
These systems include [removed: the] da Vinci surgical [removed: system,] [added: systems,] which [removed: was] [added: are] designed to enable [removed: complex surgery] [added: a wide range of surgical procedures] using a minimally invasive approach, and the Ion endoluminal system, which extends our commercial offerings beyond surgery into diagnostic procedures, enabling minimally invasive biopsies in the lung.
There are several models of the da Vinci surgical [removed: system:] [added: system currently used by] our [removed: fourth generation] [added: customers: our recently released fifth-generation] da Vinci [added: 5 surgical system, our fourth-generation da Vinci] X, da Vinci Xi, and da Vinci SP surgical systems, our [removed: third generation] [added: third-generation] da Vinci Si surgical system, [removed: our second generation da Vinci S surgical system,] and our [removed: first generation] [added: second-generation] da Vinci [removed: standard] [added: S] surgical system.
[removed: The da Vinci surgical] systems are designed to enable surgeons to perform a wide range of surgical procedures within our targeted general surgery, urologic, gynecologic, cardiothoracic, and head and neck specialties.
The surgeon’s fingers grasp instrument controls below the display [added: with the surgeon’s hands naturally positioned relative to his or her eyes.]
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
On most of our current systems (da Vinci [added: 5, da Vinci] X*,* da Vinci Xi, da Vinci SP, and da Vinci Si), a second surgeon console may be used in two ways: to provide assistance to the primary surgeon during surgery or to act as an active aid during surgeon-proctor training sessions.
With the da Vinci [added: 5, da Vinci] X*,* da Vinci Xi, da Vinci SP, and da Vinci Si, a surgeon sitting at a second console can view the same surgery as the primary surgeon and can be passed control of some or all of the da Vinci instruments during the surgery.
Because the da Vinci surgical system’s robotic arms hold the camera and instruments steady, there is less surgeon and assistant [removed: fatigue.][added: fatigue and enhanced control by the surgeon.]
For our da Vinci [removed: Xi,] [added: 5,] da Vinci X, [added: da Vinci Xi,] and da Vinci Si surgical systems, up to four arms attached to the cart can be positioned, as appropriate, and then locked into place.
The fourth instrument arm is a standard, integrated feature on the da Vinci [added: 5, da Vinci] X, da Vinci Xi, and da Vinci Si surgical systems.
[removed: *3DHD Vision System.*] Our vision system includes a 3DHD endoscope with two independent vision channels linked to two separate color monitors through sophisticated image processing electronics and software.
The 3DHD vision system is a standard, integrated feature on the da Vinci [added: 5, da Vinci] X*,* da Vinci Xi*,* da Vinci SP, da Vinci Si*,* and da Vinci S surgical systems.
Firefly is a standard feature of the da Vinci [added: 5, da Vinci] X, da Vinci Xi, and da Vinci SP *s*urgical systems and is available as an upgrade on our da Vinci Si surgical system.
*Da Vinci [removed: Xi] Integrated Table Motion*.
Integrated Table Motion coordinates the movements of the da Vinci robotic arms with an advanced operating room (“OR”) table, the TS 7000dV OR Table sold by [removed: HillromTM,] [added: Hillrom (now a part of Baxter International Inc.),] to enable managing the patient’s position in real-time while the da Vinci robotic arms remain docked.
The system features an ultra-thin, ultra-maneuverable catheter that can articulate 180 degrees in all directions and allows navigation far into the peripheral [removed: lung and provides the stability necessary for precision in a biopsy.]
[removed: Surgical Instruments] [added: Instruments] and Accessories
Most of the [removed: various] instruments that we manufacture incorporate wristed joints for natural dexterity and tips customized for various surgical procedures.
The [removed: EndoWrist and] SureForm [removed: Staplers] [added: and EndoWrist staplers] are wristed, stapling instruments intended for resection, transection, and creation of anastomoses.
We have various [removed: clearances for five] staplers that can be used with [removed: the] [added: our] da Vinci [removed: X] [added: 5, da Vinci X,] and da Vinci Xi surgical systems: the [removed: EndoWrist 30 and 45 staplers and the] SureForm 30, 45, and 60 staplers, where the numeric designation indicates the length of the staple line.
The EndoWrist 45 stapler is used in [removed: general surgery,] [added: general,] gynecologic, thoracic, and urologic [added: surgical] procedures.
The SureForm 30, 45, and 60 staplers are single-use, fully wristed, stapling instruments intended to be used in [removed: general surgery,] [added: general,] thoracic, gynecologic, urologic, and pediatric [removed: surgery] [added: surgical] procedures.
Vessel Sealer Extend is a single-use, fully wristed, advanced bipolar instrument that is compatible with our [removed: fourth-generation multi-port] [added: da Vinci 5, da Vinci X, and da Vinci Xi] surgical systems.
This instrument enables surgeons to control vessel sealing, while providing the benefits of robotic-assisted surgery, and is designed to enhance surgical efficiency and autonomy in a variety of general [removed: surgery] and gynecologic [added: surgical] procedures.
[removed: The] [added: Our first-generation] E-100 generator is [removed: Intuitive’s first generator and is] offered as an upgrade to power our da Vinci Vessel Sealer Extend and SynchroSeal instruments.
Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products, such as replacement 3D stereo endoscopes, camera heads, and light guides, and other items that facilitate [added: the] use of the da Vinci surgical systems.
Intuitive’s enabling technologies include Telepresence and the [removed: Procedure Analytics Platform.][added: Advanced Insights Suite (which includes Case Insights and Insights Engine).]
SimNow is intended to augment, not replace, existing training programs for the da Vinci [added: 5, da Vinci] X, da Vinci Xi, and da Vinci SP surgical systems.
We have a network of field service engineers across the U.S., [added: Canada,] Europe, and Asia and maintain relationships with various distributors around the globe.
Since our founding 30 years ago, we have been delivering on this mission and vision by combining innovative technology with clinical expertise to advance minimally invasive care.
Among other capabilities, these products and services can augment the skills and improve the efficiency of clinicians and care teams while providing decision support and learning that can help deliver differentiated clinical and economic value for patients, providers, and payers when compared to the next best available treatment options.
To assure continued alignment with the patients and healthcare community we serve, we have adopted the Quintuple Aim as our “north star.” Starting foremost with a focus on patients, we seek to demonstrate that our products can deliver better outcomes that are validated by rigorous peer-reviewed evidence.
Second, we aim to work with clinicians and care teams to create better patient experiences that enable patients to more quickly get back to what matters most in their lives, with fewer complications, less pain and discomfort, and greater predictability.
Third, we aim to enable the care teams who use our platforms and technology-enabled ecosystem to have better experiences that augment their skills while reducing fatigue and increasing efficiency and reliability.
Lastly, we aim to expand access to high-quality minimally invasive care by partnering with hospitals, healthcare systems, and patient advocacy groups to address barriers to care.
Stakeholders continue to expect better clinical outcomes and decreased variability of outcomes across clinicians and care teams.
Since then, we have received numerous additional indications within the U.S. as well as outside of the U.S. Refer to the section titled “Regulatory Activities” in our Management’s Discussion and Analysis of Financial Condition and Results of Operations for more recent regulatory clearances, approvals, and certification.
The da Vinci surgical
*3DHD Vision System*.
Integrated Table Motion is a standard feature for da Vinci 5 surgical systems and is available as an upgrade for da Vinci Xi surgical systems.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
lung and provides the stability necessary for precision in a biopsy.
Outside of the U.S. (“OUS”), we also offer the EndoWrist 30 and 45 staplers that can be used with our da Vinci X and da Vinci Xi surgical systems.
Additionally, we recently introduced our second-generation E-200 generator, an advanced electrosurgical generator designed to provide high-frequency energy for cutting, coagulation, and vessel sealing of tissues.
The E-200 generator is integrated with the da Vinci 5 surgical system, is compatible with our da Vinci X and Xi surgical systems, and can also function as a standalone electrosurgical generator.
Instruments and accessories are also used with our Ion endoluminal system to perform lung biopsy procedures and for the operation and maintenance of the system.
*Ion Instruments*.
Instruments utilized with our Ion system include our fully articulating catheter, which is employed to navigate the intricate and narrow airways of the lungs, our peripheral vision probe, an endoscope that provides real-time
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
airway visualization for catheter navigation, and our Flexision biopsy needles, which are used to procure tissue samples from lung nodules.
*Accessory Products*.
Accessory products that are used in conjunction with the Ion system include cleaning tools and other ancillary equipment essential for the operation and maintenance of the Ion system.
The customer portal is an online tool that enables customers to access system utilization and program
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
The Intuitive Telepresence application on Hub can be used to facilitate peer-to-peer collaboration, learning, and support.
Video captured during surgery and da Vinci system data are connected via Intuitive Hub for physicians to access after a surgical procedure, helping to facilitate personalized learning and increase efficiency.
Our goal is to provide products to
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Furthermore, we will work to increase access to minimally invasive care.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
*Prostatectomy*.
Our fully featured da Vinci 5 and da Vinci Xi surgical systems with advanced instruments (including the da Vinci energy and
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
The
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
Additionally, we have Ion-related manufacturing in Blacksburg, Virginia, and Shanghai, China, and endoscope-related manufacturing at multiple sites in Germany.
We are also planning to open a new manufacturing facility in Bulgaria.
Additionally, we currently face, or anticipate facing, competition from companies with products used in open or MIS surgeries, including laparoscopy and alternative multi-port, single-port, or endoluminal systems.
We also compete with companies providing other therapeutic approaches for addressing target clinical conditions, as well as companies developing diagnostic solutions that could serve as alternatives to current or planned Intuitive offerings.
Intuitive is committed to advancing minimally invasive care through a comprehensive ecosystem of products and services.
Intuitive brings nearly three decades of experience and technical innovation to our robotic-assisted surgical solutions.
We address our customers’ needs by sharing their goals reflected in the Quadruple Aim.
First, we focus on improving patient outcomes through an ecosystem of advanced robotic systems, instruments and accessories, progressive technology learning pathways, and comprehensive support and program assistance services.
Second, we seek to improve the patient experience by minimizing disruption to lives and creating greater predictability for the treatment experience.
Third, we seek to improve care team satisfaction by creating products and services that are dependable, smart, and optimized for the care environment in which they are used.
To date, surgeons have used the da Vinci surgical system to perform dozens of different types of surgical procedures.
with the surgeon’s hands naturally positioned relative to his or her eyes.
In 2020, we announced our “Extended Use Program,” which consists of select da Vinci Xi and da Vinci X instruments possessing 12 to 18 uses (“Extended Use Instruments”) compared to the previous 10 uses.
These Extended Use Instruments represent some of our higher volume instruments but exclude stapling, monopolar, and advanced energy instruments.
Instruments included in the program are used across a number of da Vinci surgeries.
Their increased uses are the result of continuous, significant investments in the design and production capabilities of our instruments, resulting in improved quality and durability.
Extended Use Instruments were introduced in the U.S. and Europe in the fourth quarter of 2020 and were launched in most other countries around the world during the first half of 2021, except China, where they were launched in the second half of 2023.
We believe that, as of the end of 2021, in the U.S. and Europe, full cutover to Extended Use Instruments had occurred, as customers had substantially utilized all of their remaining 10 use instruments.
Vessel Sealer Extend is also compatible with certain third-party electrosurgical generators.
For surgeons, Intuitive Hub connects video and other data that can be accessed after a surgical procedure to help facilitate personalized learning and increased efficiency.
Using
We also have manufacturing at multiple sites in Germany.
Additionally, we face or expect to face competition from companies that have developed or may develop wristed, robotic- or computer-assisted medical systems and products.
Upon expiration, the inventions claimed in a patent enter the public domain.
with the FDA’s investigational device exemption (“IDE”) regulations, which govern investigational device labeling, prohibit the promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
operations of our partners.
China has its own regulatory agency.
National reimbursement status in Japan was received for prostatectomy procedures in April 2012 and for da Vinci partial nephrectomy procedures in April 2016.
An additional seven da Vinci procedures were granted reimbursement effective April 1, 2020.
An additional eight da Vinci procedures were granted reimbursement effective April 1, 2022, including colon resection.
reimbursement or incremental reimbursement to the MHLW for their evaluation.
In the EU, all medical devices placed on the EU market must meet the essential requirements, including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner.
Pursuing marketing of medical devices in the EU requires that our devices be certified under the new regime set forth in the MDR, and we are diligently pursuing our plan to be fully compliant by May 26, 2024.
*Brexit*
Regulations implementing the new regime were originally scheduled to come into force in July 2023 but the MHRA has recently confirmed that it is now aiming for the core aspects of the new regime to apply from July 1, 2025.
Devices bearing CE marks issued by EU notified bodies under the MDR or MDD are now subject to transitional arrangements.
The UK Government has introduced legislation that provides that CE-marked medical devices may be placed on the Great Britain market on the following timelines:
- general medical devices compliant with the EU MDD or EU active implantable medical devices directive with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of the certificate or June 30, 2028; and
- general medical devices, including custom-made devices, compliant with the EU MDR can be placed on the Great Britain market up until June 30, 2030.
Following these transitional periods, it is anticipated that all medical devices will require a UK Conformity Assessed (“UKCA”) mark in order to be placed on the market in Great Britain.
Manufacturers may choose to use the UKCA mark on a voluntary basis prior to entry of the new regulations on July 1, 2025.
However, from July 2025, products that do not have existing and valid certification under the EU Medical Devices Directive or EU MDR and, therefore, are not subject to the transitional arrangements will be required to carry the UKCA mark if they are to be sold into the market in Great Britain.
For products to be sold into the market in Northern Ireland, CE marking will continue to be recognized as a result of the Northern Ireland Protocol implemented following the UK’s exit from the EU.
An excerpt. Shown here: 40 of 130 rewritten, 40 of 81 added and 40 of 63 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2024 filing and the FY2023 filing.
Item 3. LEGAL PROCEEDINGS
1 rewritten, 0 added, 0 removed, 0 unchanged
The information included in [Note 8 to the Consolidated Financial [removed: Statements](#idedd11384ae3443fb7ca452b61ce97d8_250)] [added: Statements](#i4ebfb7d693504e7ea6b45dad3395a031_259)] included in Part II, Item 8 of this report is incorporated herein by reference.
Cover and table of contents
46 rewritten, 9 added, 5 removed, 142 unchanged
For the fiscal year ended December 31, [removed: 2023][added: 2024]
[removed: ][added: ]
The aggregate market value of the voting and non-voting common equity held by non-affiliates on June 30, [removed: 2023,] [added: 2024,] based upon the closing price of Common Stock on such date as reported on The Nasdaq Global Select Market, was approximately [removed: $119.6] [added: $157.3] billion.
The number of outstanding shares of the registrant’s common stock as of January [removed: 25, 2024,] [added: 27, 2025,] was [removed: 352,325,863.][added: 356,656,964.]
Part III incorporates information by reference to the definitive proxy statement for the Company’s Annual Meeting of Stockholders to be held on or about [removed: April 25, 2024,] [added: May 1, 2025,] to be filed within 120 days of the registrant’s fiscal year ended December 31, [removed: 2023.][added: 2024.]
| [Item [removed: 1.](#idedd11384ae3443fb7ca452b61ce97d8_19)] [added: 1.](#i4ebfb7d693504e7ea6b45dad3395a031_19)] | | | [removed: [Business](#idedd11384ae3443fb7ca452b61ce97d8_19)] [added: [Business](#i4ebfb7d693504e7ea6b45dad3395a031_19)] | | | [removed: [6](#idedd11384ae3443fb7ca452b61ce97d8_19)] [added: [6](#i4ebfb7d693504e7ea6b45dad3395a031_19)] | | |
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[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
This report contains [removed: “forward-looking statements”] [added: forward-looking statements] within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as [removed: amended (the “Exchange Act”).][added: amended.]
These forward-looking statements include, but are not limited to, statements related to future results of operations, future financial condition, the expected impacts of COVID-19 on our business, financial condition, and results of operations, our financing plans and future capital requirements, our potential tax assets or liabilities, and statements based on current expectations, estimates, forecasts, and projections about the economies and [added: geographic] markets in which we operate and our beliefs and assumptions regarding these economies and markets.
These forward-looking statements should be considered in light of various important factors, including, but not limited to, the following: the overall macroeconomic environment, which may impact customer spending and our costs, including [added: tariffs,] the levels of [removed: inflation] [added: inflation,] and interest rates; the conflict [removed: in Ukraine; the conflict] between [removed: Israel] [added: Ukraine] and [removed: Hamas;] [added: Russia; conflicts in the Middle East;] disruption to our supply chain, including [removed: increased] difficulties in obtaining a sufficient supply of [removed: materials in the semiconductor and other markets;] [added: materials;] curtailed or delayed capital spending by hospitals; the impact of global and regional economic and credit market conditions on healthcare spending; [removed: the risk that COVID-19 could lead to material] delays [removed: and cancellations of, or reduced demand for, procedures; closures of our facilities; delays] in [removed: surgeon training; delays in gathering clinical evidence; delays in] obtaining new product approvals, clearances, or certifications from the [removed: U.S.] Food and Drug Administration (“FDA”), comparable regulatory authorities, or notified bodies; [removed: diversion of resources to respond to COVID-19 outbreaks;] the risk of our inability to comply with complex FDA and other regulations, which may result in significant enforcement actions; regulatory approvals, clearances, certifications, and restrictions or any dispute that may occur with any regulatory body; [removed: guidelines and recommendations in the] healthcare [removed: and patient communities; healthcare] reform legislation in the U.S. and its impact on hospital spending, reimbursement, and fees levied on certain medical device revenues; changes in hospital admissions and actions by payers to limit or manage surgical procedures; the timing and success of product development and [removed: market] [added: customer] acceptance of developed products; the results of any collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships, including the joint venture with Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; our completion of and ability to successfully integrate acquisitions; [removed: procedure counts;] intellectual property positions and litigation; [removed: competition in the medical device industry and in the specific markets of surgery in which we operate;] risks associated with our operations and any expansion outside of the [removed: United States;] [added: U.S.;] unanticipated manufacturing disruptions or the inability to meet demand for products; our reliance on sole- and single-sourced suppliers; the results of legal proceedings to which we are or may become a [removed: party, including, but not limited to, product liability claims;] [added: party;] adverse publicity regarding us and the safety of our products and adequacy of training; the impact of changes to tax legislation, guidance, and interpretations; changes in tariffs, trade barriers, and regulatory [removed: requirements;] [added: requirements (including potential new tariffs imposed by the current U.S. presidential administration on imports from Mexico, where we currently manufacture a significant majority of our instruments] and [added: accessories); and] other risks and uncertainties, including those listed under the caption “Risk Factors.” Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report and which are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict.
- We experience long and variable [removed: capital sales] [added: contracting] cycles and seasonality in our business, which may cause fluctuations in our financial results.
- We offer [added: usage-based arrangements, including] alternative capital acquisition [removed: approaches and,] [added: approaches;] as a result, we are exposed to [removed: the credit risk of some of our customers and the] [added: an increased] risk of losses of [removed: revenue,] [added: revenue and increased credit risk,] which could [removed: result in material losses.][added: adversely affect our business, financial condition, or results of operations.]
- Third parties may offer to sell [removed: to our customers] remanufactured [removed: and/or] [added: or] unauthorized instruments and accessories [removed: or] to [added: our customers or provide unauthorized] service [added: on] our systems, which could [removed: negatively] [added: adversely] impact safety, our financial results, and our reputation.
- Our business is subject to complex and evolving laws and regulations regarding [added: data] privacy, data protection, [added: artificial intelligence,] and [removed: other matters relating to information collection.][added: responsible use of data.]
- Ongoing and [removed: potential] future global conflicts could adversely affect our business, financial condition, or results of operations.
- Incorporating artificial intelligence [added: technologies] into our products, services, and operations may result in legal and regulatory risks or [removed: reputational harm or] have other adverse consequences to our business, financial condition, or results of operations.
- If we do not successfully manage our collaboration, licensing, joint venture, strategic alliance, or partnership arrangements with third parties, we may not realize the expected benefits from such arrangements, which may have a [removed: material adverse effect on our business, financial condition, or results of operations.]
- [removed: Continued consolidation] [added: Consolidation] in the healthcare industry could have an adverse effect on our business, financial condition, or results of operations.
| [PART I](#i4ebfb7d693504e7ea6b45dad3395a031_16) | | | | | | | | |
| [PART II](#i4ebfb7d693504e7ea6b45dad3395a031_97) | | | | | | | | |
| [PART III](#i4ebfb7d693504e7ea6b45dad3395a031_304) | | | | | | | | |
| [PART IV](#i4ebfb7d693504e7ea6b45dad3395a031_322) | | | | | | | | |
| [SIGNATURES](#i4ebfb7d693504e7ea6b45dad3395a031_334) | | | | | | [130](#i4ebfb7d693504e7ea6b45dad3395a031_334) | | |
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
material adverse effect on our business, financial condition, or results of operations.
[Table](#i4ebfb7d693504e7ea6b45dad3395a031_7) [of Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)
| [PART I](#idedd11384ae3443fb7ca452b61ce97d8_16) | | | | | | | | |
| [PART II](#idedd11384ae3443fb7ca452b61ce97d8_91) | | | | | | | | |
| [PART III](#idedd11384ae3443fb7ca452b61ce97d8_292) | | | | | | | | |
| [PART IV](#idedd11384ae3443fb7ca452b61ce97d8_310) | | | | | | | | |
| [SIGNATURES](#idedd11384ae3443fb7ca452b61ce97d8_322) | | | | | | [131](#idedd11384ae3443fb7ca452b61ce97d8_322) | | |
An excerpt. Shown here: 40 of 46 rewritten, all 9 added and all 5 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2024 filing and the FY2023 filing.
Item 1C. CYBERSECURITY
4 rewritten, 0 added, 0 removed, 30 unchanged
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
- risk assessments designed to help identify material cybersecurity risks to our critical systems, information, products, services, and our broader enterprise information technology [removed: (“IT”)] environment;
[removed: Six] [added: Seven] members of our Board [removed: of Directors] have information security expertise, including Joseph C.
Beery, [added: Lewis Chew,] Gary S.
Item 2. PROPERTIES
4 rewritten, 0 added, 1 removed, 3 unchanged
As of December 31, [removed: 2023,] [added: 2024,] we own approximately [removed: 2.0] [added: 2.1] million square feet of space on [removed: 142] [added: 128] acres of land in Sunnyvale, California, where we house our principal headquarters, research and development, service, and support functions, as well as certain of our manufacturing operations.
Outside of Sunnyvale, California, we own facilities in other U.S. locations that are used for sales, training, manufacturing, engineering, and administrative functions, including approximately [removed: 520,000] [added: 1.1 million] square feet of space on 69 acres of land in Peachtree Corners, Georgia.
We also lease approximately [removed: 830,000] [added: 740,000] square feet of space for certain [added: manufacturing,] engineering, warehousing, and support functions at various locations in the U.S.
Outside of the U.S., we own and/or lease properties in Mexicali, Mexico, [removed: and] Germany, [added: and Bulgaria,] primarily for manufacturing operations, and Aubonne, Switzerland, primarily for our international headquarters.
[Table](#idedd11384ae3443fb7ca452b61ce97d8_7) [of Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)
Item 4. MINE SAFETY DISCLOSURES
1 rewritten, 0 added, 0 removed, 2 unchanged
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
12 rewritten, 5 added, 5 removed, 27 unchanged
As of January [removed: 25, 2024,] [added: 27, 2025,] there were [removed: 132] [added: 124] stockholders of record of our common stock, although there are a significantly larger number of beneficial owners of our common stock.
The table below summarizes our [added: common] stock repurchase activity for the quarter ended December 31, [removed: 2023.][added: 2024.]
| November 1 to November 30, [removed: 2023] [added: 2024] | | | [removed: 22,585] [added: —] | | | | | | $ | [removed: 265.01] [added: —] | | | | | [removed: 22,585] [added: —] | | | | | | $ | 1.1 | billion |
| December 1 to December 31, [removed: 2023] [added: 2024] | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 1.1 | billion |
| Total during quarter ended December 31, [removed: 2023] [added: 2024] | | | [removed: 254,917] [added: —] | | | | | | $ | [removed: 260.04] [added: —] | | | | | [removed: 254,917] [added: —] | | | | | | | | |
As of December 31, [removed: 2023,] [added: 2024,] our Board of Directors (our “Board”) had authorized an aggregate amount of up to $10.0 billion for stock repurchases, of which the most recent authorization occurred in July 2022, when our Board increased the authorized amount available under our Repurchase Program to $3.5 billion.
The remaining amount available to repurchase shares under the authorized Repurchase Program as of December 31, [removed: 2023, is] [added: 2024, was] $1.1 billion.
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
The graph set forth below compares the cumulative total stockholder return on our common stock between December 31, [removed: 2018,] [added: 2019,] and December 31, [removed: 2023,] [added: 2024,] with the cumulative total return of (i) the Nasdaq Composite Index, (ii) the S&P 500 Healthcare Index, and (iii) the S&P 500 Index over the same period.
This graph assumes an investment of $100.00 on December 31, [removed: 2018,] [added: 2019,] in our common stock, the Nasdaq Composite Index, the S&P Healthcare Index, and the S&P 500 Index and assumes the re-investment of dividends, if any.
[removed: ][added: ]
| | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2023] [added: 2024] | | |
| October 1 to October 31, 2024 | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 1.1 | billion |
| Intuitive Surgical, Inc. | | | $ | 100.00 | | | | | $ | 138.39 | | | | | $ | 182.34 | | | | | $ | 134.66 | | | | | $ | 171.21 | | | | | $ | 264.89 | |
| Nasdaq Composite | | | $ | 100.00 | | | | | $ | 144.92 | | | | | $ | 177.06 | | | | | $ | 119.45 | | | | | $ | 172.77 | | | | | $ | 223.87 | |
| S&P 500 Healthcare Index | | | $ | 100.00 | | | | | $ | 111.43 | | | | | $ | 138.35 | | | | | $ | 133.44 | | | | | $ | 133.85 | | | | | $ | 135.06 | |
| S&P 500 Index | | | $ | 100.00 | | | | | $ | 118.40 | | | | | $ | 152.39 | | | | | $ | 124.79 | | | | | $ | 157.59 | | | | | $ | 197.02 | |
| October 1 to October 31, 2023 | | | 232,332 | | | | | | $ | 259.56 | | | | | 232,332 | | | | | | $ | 1.1 | billion |
| Intuitive Surgical, Inc. | | | $ | 100.00 | | | | | $ | 123.43 | | | | | $ | 170.82 | | | | | $ | 225.07 | | | | | $ | 166.22 | | | | | $ | 211.33 | |
| Nasdaq Composite | | | $ | 100.00 | | | | | $ | 136.69 | | | | | $ | 198.10 | | | | | $ | 242.03 | | | | | $ | 163.28 | | | | | $ | 236.17 | |
| S&P 500 Healthcare Index | | | $ | 100.00 | | | | | $ | 118.68 | | | | | $ | 132.24 | | | | | $ | 164.20 | | | | | $ | 158.37 | | | | | $ | 158.85 | |
| S&P 500 Index | | | $ | 100.00 | | | | | $ | 131.49 | | | | | $ | 155.68 | | | | | $ | 200.37 | | | | | $ | 164.08 | | | | | $ | 207.21 | |
Item 6. [RESERVED]
1 rewritten, 0 added, 0 removed, 1 unchanged
[removed: [Table](#idedd11384ae3443fb7ca452b61ce97d8_7)] [added: [Table](#i4ebfb7d693504e7ea6b45dad3395a031_7)] [of [removed: Contents](#idedd11384ae3443fb7ca452b61ce97d8_7)][added: Contents](#i4ebfb7d693504e7ea6b45dad3395a031_7)]
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
456 rewritten, 169 added, 135 removed, 845 unchanged
| [Report of Independent Registered Public Accounting [removed: Firm](#idedd11384ae3443fb7ca452b61ce97d8_208)] [added: Firm](#i4ebfb7d693504e7ea6b45dad3395a031_217)] – | | | PCAOB ID: | | | 238 | | | [removed: [89](#idedd11384ae3443fb7ca452b61ce97d8_208)] [added: [88](#i4ebfb7d693504e7ea6b45dad3395a031_217)] | | |
| [Consolidated Balance Sheets as of December [removed: 31,](#idedd11384ae3443fb7ca452b61ce97d8_211) 2023[, and](#idedd11384ae3443fb7ca452b61ce97d8_211) 2022] [added: 31,](#i4ebfb7d693504e7ea6b45dad3395a031_220) 2024[, and](#i4ebfb7d693504e7ea6b45dad3395a031_220) 2023] | | | | | | | | | [removed: [90](#idedd11384ae3443fb7ca452b61ce97d8_211)] [added: [89](#i4ebfb7d693504e7ea6b45dad3395a031_220)] | | |
| [Consolidated Statements of Income for the years ended December [removed: 31,](#idedd11384ae3443fb7ca452b61ce97d8_214) 2023[,](#idedd11384ae3443fb7ca452b61ce97d8_214) 2022[, and](#idedd11384ae3443fb7ca452b61ce97d8_214) 2021] [added: 31,](#i4ebfb7d693504e7ea6b45dad3395a031_223) 2024[,](#i4ebfb7d693504e7ea6b45dad3395a031_223) 2023[, and](#i4ebfb7d693504e7ea6b45dad3395a031_223) 2022] | | | | | | | | | [removed: [91](#idedd11384ae3443fb7ca452b61ce97d8_214)] [added: [90](#i4ebfb7d693504e7ea6b45dad3395a031_223)] | | |
| [Consolidated Statements of Comprehensive Income for the years ended December [removed: 31,](#idedd11384ae3443fb7ca452b61ce97d8_217) 2023[,](#idedd11384ae3443fb7ca452b61ce97d8_217) 2022[, and](#idedd11384ae3443fb7ca452b61ce97d8_217) 2021] [added: 31,](#i4ebfb7d693504e7ea6b45dad3395a031_226) 2024[,](#i4ebfb7d693504e7ea6b45dad3395a031_226) 2023[, and](#i4ebfb7d693504e7ea6b45dad3395a031_226) 2022] | | | | | | | | | [removed: [92](#idedd11384ae3443fb7ca452b61ce97d8_217)] [added: [91](#i4ebfb7d693504e7ea6b45dad3395a031_226)] | | |
| [Consolidated Statements of Stockholders’ Equity for the years ended December [removed: 31,](#idedd11384ae3443fb7ca452b61ce97d8_220) 2023[,](#idedd11384ae3443fb7ca452b61ce97d8_220) 2022[, and](#idedd11384ae3443fb7ca452b61ce97d8_220) 2021] [added: 31,](#i4ebfb7d693504e7ea6b45dad3395a031_229) 2024[,](#i4ebfb7d693504e7ea6b45dad3395a031_229) 2023[, and](#i4ebfb7d693504e7ea6b45dad3395a031_229) 2022] | | | | | | | | | [removed: [93](#idedd11384ae3443fb7ca452b61ce97d8_220)] [added: [92](#i4ebfb7d693504e7ea6b45dad3395a031_229)] | | |
| [Consolidated Statements of Cash Flows for the years ended December [removed: 31,](#idedd11384ae3443fb7ca452b61ce97d8_223) 2023[,](#idedd11384ae3443fb7ca452b61ce97d8_223) 2022[, and](#idedd11384ae3443fb7ca452b61ce97d8_223) 2021] [added: 31,](#i4ebfb7d693504e7ea6b45dad3395a031_232) 2024[,](#i4ebfb7d693504e7ea6b45dad3395a031_232) 2023[, and](#i4ebfb7d693504e7ea6b45dad3395a031_232) 2022] | | | | | | | | | [removed: [94](#idedd11384ae3443fb7ca452b61ce97d8_223)] [added: [93](#i4ebfb7d693504e7ea6b45dad3395a031_232)] | | |
| [Notes to the Consolidated Financial [removed: Statements](#idedd11384ae3443fb7ca452b61ce97d8_226)] [added: Statements](#i4ebfb7d693504e7ea6b45dad3395a031_235)] | | | | | | | | | [removed: [95](#idedd11384ae3443fb7ca452b61ce97d8_226)] [added: [94](#i4ebfb7d693504e7ea6b45dad3395a031_235)] | | |
| [Schedule II—Valuation and Qualifying [removed: Accounts](#idedd11384ae3443fb7ca452b61ce97d8_277)] [added: Accounts](#i4ebfb7d693504e7ea6b45dad3395a031_286)] | | | | | | | | | [removed: [125](#idedd11384ae3443fb7ca452b61ce97d8_277)] [added: [124](#i4ebfb7d693504e7ea6b45dad3395a031_286)] | | |
We have audited the accompanying consolidated balance sheets of Intuitive Surgical, Inc. and its subsidiaries (the “Company”) as of December 31, [removed: 2023] [added: 2024,] and [removed: 2022,] [added: 2023,] and the related consolidated statements of income, of comprehensive income, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] including the related notes and financial statement schedule listed in the index appearing under Item 15(a)(2) (collectively referred to as the “consolidated financial statements”).
We also have audited the Company’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2023] [added: 2024,] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] in conformity with accounting principles generally accepted in the United States of America.
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.
[removed: Determination] [added: *Determination] of Standalone Selling Prices Related to System Sale [removed: Arrangements][added: Arrangements*]
As described in Notes 2 and 5 to the consolidated financial statements, the Company recognized [removed: $1,679.7] [added: $1,966.0] million of systems [removed: revenue,] [added: revenue] during the year ended December 31, [removed: 2023.][added: 2024, of which a majority relates to system sale arrangements.]
If a standalone selling price is not directly observable, then management estimates the standalone selling price considering market conditions and entity-specific factors including, but not limited to, [added: historical pricing data,] features and functionality of the products and services, geographies, and type of customer.
| | | | [added: 2024 | | | | | |] 2023 | | | | | | 2022 | | |
| Cash and cash equivalents | | | $ | [removed: 2,750.1] [added: 2,027.4] | | | | | $ | [removed: 1,581.2] [added: 2,750.1] | |
| Short-term investments | | | [removed: 2,473.1] [added: 1,985.9] | | | | | | [removed: 2,536.7] [added: 2,473.1] | | |
| Accounts receivable, net of allowances of [removed: $27.1] [added: $30.7] and [removed: $22.4] [added: $27.1] as of December 31, [removed: 2023,] [added: 2024,] and [removed: 2022,] [added: 2023,] respectively | | | [removed: 1,130.2] [added: 1,225.4] | | | | | | [removed: 942.1] [added: 1,130.2] | | |
| Inventory | | | [removed: 1,220.6] [added: 1,487.2] | | | | | | [removed: 893.2] [added: 1,220.6] | | |
| Prepaids and other current assets | | | [removed: 314.0] [added: 385.1] | | | | | | [removed: 299.8] [added: 314.0] | | |
| Total current assets | | | [removed: 7,888.0] [added: 7,111.0] | | | | | | [removed: 6,253.0] [added: 7,888.0] | | |
| Property, plant, and equipment, net | | | [removed: 3,537.6] [added: 4,646.6] | | | | | | [removed: 2,374.2] [added: 3,537.6] | | |
| Long-term investments | | | [removed: 2,120.0] [added: 4,819.1] | | | | | | [removed: 2,623.6] [added: 2,120.0] | | |
| Deferred tax assets | | | [removed: 910.5] [added: 1,045.1] | | | | | | [removed: 664.6] [added: 910.5] | | |
| Intangible and other assets, net | | | [removed: 636.7] [added: 773.9] | | | | | | [removed: 710.1] [added: 636.7] | | |
| Goodwill | | | [removed: 348.7] [added: 347.5] | | | | | | [removed: 348.5] [added: 348.7] | | |
| Total assets | | | $ | [removed: 15,441.5] [added: 18,743.2] | | | | | $ | [removed: 12,974.0] [added: 15,441.5] | |
| Accounts payable | | | $ | [removed: 188.7] [added: 193.4] | | | | | $ | [removed: 147.0] [added: 188.7] | |
| Accrued compensation and employee benefits | | | [removed: 436.4] [added: 535.6] | | | | | | [removed: 401.6] [added: 436.4] | | |
| Deferred revenue | | | [removed: 446.1] [added: 468.8] | | | | | | [removed: 397.3] [added: 446.1] | | |
| Other accrued liabilities | | | [removed: 587.5] [added: 547.5] | | | | | | [removed: 476.2] [added: 587.5] | | |
| Total current liabilities | | | [removed: 1,658.7] [added: 1,745.3] | | | | | | [removed: 1,422.1] [added: 1,658.7] | | |
| Other long-term liabilities | | | [removed: 385.5] [added: 468.3] | | | | | | [removed: 439.3] [added: 385.5] | | |
| Total liabilities | | | [removed: 2,044.2] [added: 2,213.6] | | | | | | [removed: 1,861.4] [added: 2,044.2] | | |
| Preferred stock, 2.5 shares authorized, $0.001 par value, issuable in series; zero shares issued and outstanding as of December 31, [removed: 2023,] [added: 2024,] and [removed: 2022] [added: 2023] | | | — | | | | | | — | | |
| Common stock, 600.0 shares authorized, $0.001 par value, [removed: 352.3] [added: 356.6] shares and [removed: 350.0] [added: 352.3] shares issued and outstanding as of December 31, [removed: 2023,] [added: 2024,] and [removed: 2022,] [added: 2023,] respectively | | | 0.4 | | | | | | 0.4 | | |
| Additional paid-in capital | | | [removed: 8,576.4] [added: 9,681.3] | | | | | | [removed: 7,703.9] [added: 8,576.4] | | |
| Retained earnings | | | [removed: 4,743.0] [added: 6,803.3] | | | | | | [removed: 3,500.1] [added: 4,743.0] | | |
| Accumulated other comprehensive loss | | | [removed: (12.2)] [added: (51.3)] | | | | | | [removed: (162.5)] [added: (12.2)] | | |
January 31, 2025
| | | | 2024 | | | | | | 2023 | | |
| Cash dividends declared and paid by joint venture | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (8.0) | | | | | | (8.0) | | |
| Balances as of December 31, 2024 | | | 356.6 | | | | | | $ | 0.4 | | | | | $ | 9,681.3 | | | | | $ | 6,803.3 | | | | | $ | (51.3) | | | | | $ | 16,433.7 | | | | | $ | 95.9 | | | | | $ | 16,529.6 | |
| Net income | | | $ | 2,337.5 | | | | | $ | 1,817.3 | | | | | $ | 1,344.4 | |
| Cash dividends paid by joint venture to noncontrolling interest | | | (8.0) | | | | | | — | | | | | | — | | |
Supply chain constraints have generally improved to pre-COVID-19 pandemic levels, with some isolated residual stresses, particularly for engineered raw materials and at certain subcontract suppliers that are operationally challenged to meet the
Company’s production requirements.
These isolated instances did not have a material impact during 2024.
Additionally, material and labor prices to produce some components remain elevated from historical levels due to market dynamics, demand mix, or general cost inflation within the supply chain.
Incidents of cybersecurity breaches, which have not significantly impacted the Company’s supply chain to date, also remain an active threat to sustained supply continuity.
Hospitals may also be adversely affected by the liquidity concerns as a result of the broader macroeconomic environment.
Any or all of these factors could negatively impact the number of da Vinci procedures performed or surgical systems placed and have a material adverse effect on the Company’s business, financial condition, or results of operations.
Amounts included in restricted cash primarily relate to the Company’s insurance programs and certain employee-related benefits.
Restricted cash included in prepaids and other current assets as of December 31, 2024, and 2023 was $20.0 million and $5.0 million, respectively.
The salvage value of operating lease assets is estimated based on a number of factors including, but not limited to, the lease term, technological obsolescence, and the expected future demand for refurbished systems.
Depreciation is recognized over the following estimated useful lives:
Goodwill represents the excess
*Transactions involving system trade-ins*
The remaining consideration is then allocated to each performance obligation based on their relative fair value.
*Purchases of system components*
Capitalized contract acquisition costs are recorded within intangible and other assets, net and are amortized over their economic life on a straight-line basis.
During the years ended December 31, 2024, 2023, and 2022, the Company recognized $37.7 million, $33.0 million, and $26.6 million of amortization expense associated with contract acquisition assets, respectively.
System upgrade transactions generally will result in a modification of the existing lease.
The Company accounts for lease modifications at the time a new or amended contract is executed.
| High | | | $ | 73.2 | | | | | $ | 30.0 | | | | | $ | 41.7 | | | | | $ | 31.4 | | | | | $ | 7.4 | | | | | | | | $ | 0.7 | | | | | $ | 184.4 | |
| Moderate | | | 82.8 | | | | | | 23.7 | | | | | | 43.1 | | | | | | 27.5 | | | | | | 11.2 | | | | | | | | | 1.1 | | | | | | 189.4 | | |
| Low | | | 2.1 | | | | | | 1.0 | | | | | | 0.9 | | | | | | 1.5 | | | | | | 0.2 | | | | | | | | | — | | | | | | 5.7 | | |
| Total | | | $ | 158.1 | | | | | $ | 54.7 | | | | | $ | 85.7 | | | | | $ | 60.4 | | | | | $ | 18.8 | | | | | | | | $ | 1.8 | | | | | $ | 379.5 | |
Intuitive adopted ASU 2023-07 effective December 31, 2024, on a retrospective basis.
The adoption of 2023-07 did not change the way that the Company identifies its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures.
Refer to Note 13 for further information on Intuitive’s reportable segment.
In November 2024, the FASB issued ASU 2024-03, *Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses* (“ASU 2024-03”), which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement.
The new disclosure requirements are effective for the Company’s annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted.
| December 31, 2024 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cash | | | $ | 479.4 | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | 479.4 | | | | | $ | 479.4 | | | | | $ | — | | | | | $ | — | |
| U.S. treasuries | | | 6,011.5 | | | | | | 13.2 | | | | | | (27.5) | | | | | | — | | | | | | 5,997.2 | | | | | | 31.9 | | | | | | 1,637.4 | | | | | | 4,327.9 | | |
| Subtotal | | | 7,527.6 | | | | | | 13.2 | | | | | | (27.5) | | | | | | — | | | | | | 7,513.3 | | | | | | 1,548.0 | | | | | | 1,637.4 | | | | | | 4,327.9 | | |
| Corporate debt securities | | | 287.5 | | | | | | 0.1 | | | | | | (3.7) | | | | | | (0.1) | | | | | | 283.8 | | | | | | — | | | | | | 189.7 | | | | | | 94.1 | | |
| U.S. government agencies | | | 552.2 | | | | | | 1.5 | | | | | | (2.4) | | | | | | — | | | | | | 551.3 | | | | | | — | | | | | | 154.2 | | | | | | 397.1 | | |
January 31, 2024
| Balances as of December 31, 2020 | | | 353.1 | | | | | | $ | 0.4 | | | | | $ | 6,444.9 | | | | | $ | 3,261.3 | | | | | $ | 24.9 | | | | | $ | 9,731.5 | | | | | $ | 27.6 | | | | | $ | 9,759.1 | |
Common Stock Split
Shares issued pursuant to the three-for-one stock split (the “Stock Split”) of the Company’s issued and outstanding common stock, par value $0.001 per share, were distributed on October 4, 2021, to stockholders of record as of September 27, 2021.
All share and per-share information presented in the Consolidated Financial Statements have been retroactively adjusted to reflect the Stock Split.
barriers, or regulatory requirements, and uncertain or reduced demand, as well as the impact of any initiatives or programs that the Company may undertake to address financial and operational challenges faced by its customers.
Supply chain constraints continued to show improvement through 2023 based on fewer market constraints.
Notably, supply of semiconductor materials rebounded while certain residual stresses remain.
Additionally, prices of such materials remain elevated due to either market demand or production-related cost inflation.
Global shortages in important components have resulted in, and will continue to cause, inflationary cost pressure in the Company’s supply chain.
To date, these supply chain challenges have not materially impacted the Company’s results of operations or ability to deliver products and services to its customers.
However, supply constraints with certain materials, which may be unavoidable, could delay the timing of our product deliveries, which could result in deferred or canceled procedures.
Additionally, if inflationary pressures in component costs persist, the Company may not be able to quickly or easily adjust pricing, reduce costs, or implement countermeasures.
Also, there is continued uncertainty surrounding the impact of any monetary policy changes taken by the U.S. Federal Reserve and other central banks to address the structural risks associated with inflation.
Fluctuations in labor availability globally, including labor shortages and staff burnout and attrition, could also impact the Company’s ability to hire and retain personnel critical to its manufacturing, logistics, and commercial operations.
The Company is also highly dependent on the principal members of its management and scientific staff.
The loss of critical members of the Company’s team, or its inability to attract and retain qualified personnel, could significantly harm its operations, business, and ability to compete.
Hospitals may also be adversely affected by the liquidity concerns in the broader financial services industry that could result in delayed access or loss of access to uninsured deposits or loss of their ability to draw on existing credit facilities involving a troubled or failed financial institution.
To the extent macroeconomic conditions remain challenging, it is likely that hospitals’ spend on capital equipment will be adversely impacted.
In addition, as overall competition for medical technologies, including robotic-assisted devices and other treatment options, progresses in various markets, longer selling cycles and pricing pressures are likely to result.
The Company maintains the majority of its cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits exceed insured limits.
Market conditions could impact the viability of these institutions.
To date, these market conditions and liquidity concerns have not impacted our results of operations.
However, in the event of the failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all.
Any inability to access or delay in accessing these funds could adversely affect our business and financial position.
The Company is also subject to additional risks and uncertainties due to COVID-19.
When COVID-19 infection rates have spiked in a particular region in the past, procedure volumes were often negatively impacted and the diagnoses of new conditions and their related treatments were sometimes deferred.
The Company’s customers may divert resources to treat COVID-19 patients and defer some elective surgical procedures, both of which may impact the Company’s customers’ ability to meet their obligations, including to the Company.
The severity of the impact of COVID-19 on the Company’s business will depend on a number of factors, including, but not limited to, the extent and severity of the impact on the Company’s customers, which is uncertain and cannot be predicted.
As of December 31, 2023, and 2022, the Company had $20.0 million and $19.5 million, respectively, of restricted cash primarily associated with its insurance programs.
legally enforceable to be performance obligations.
The Company regularly reviews the allowance by considering factors such as historical
| High | | | $ | 39.6 | | | | | $ | 70.2 | | | | | $ | 60.3 | | | | | $ | 24.4 | | | | | $ | 6.5 | | | | | | | | $ | 0.2 | | | | | $ | 201.2 | |
| Moderate | | | 37.6 | | | | | | 51.4 | | | | | | 43.1 | | | | | | 22.2 | | | | | | 4.5 | | | | | | | | | 1.0 | | | | | | 159.8 | | |
| Low | | | 1.5 | | | | | | 4.6 | | | | | | 3.5 | | | | | | 0.8 | | | | | | — | | | | | | | | | 0.2 | | | | | | 10.6 | | |
| Total | | | $ | 78.7 | | | | | $ | 126.2 | | | | | $ | 106.9 | | | | | $ | 47.4 | | | | | $ | 11.0 | | | | | | | | $ | 1.4 | | | | | $ | 371.6 | |
Segments
The chief operating decision maker regularly reviews the operating results of the Company on a consolidated basis as part of making decisions for allocating resources and evaluating performance.
As of both December 31, 2023, and 2022, 84% of long-lived assets were in the United States.
*Troubled Debt Restructurings and Vintage Disclosures*
An excerpt. Shown here: 40 of 456 rewritten, 40 of 169 added and 40 of 135 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2024 filing and the FY2023 filing.
Item 9A. CONTROLS AND PROCEDURES
3 rewritten, 0 added, 0 removed, 20 unchanged
Based on the results of our assessment under the framework in the Internal Control—Integrated Framework (2013), our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2023.][added: 2024.]
The effectiveness of our internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which is included under “Item 8.
There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, [removed: 2023,] [added: 2024,] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. OTHER INFORMATION
8 rewritten, 6 added, 3 removed, 5 unchanged
Rosa, the Company’s [removed: President,] [added: President and a member of the Company’s Board of Directors,] adopted a Rule 10b5-1 trading plan.
Mr. Rosa’s trading plan provides for the potential exercise and sale of up to [removed: 140,850] [added: 29,250] shares of the Company’s common stock subject to stock options, until [removed: February 14,] [added: December 4,] 2025.
[removed: Mohr,] [added: Loeb,] the Company’s Executive Vice [removed: President, Global Business Services,] [added: President and Chief Legal and Compliance Officer,] adopted a Rule 10b5-1 trading plan.
Mr. [removed: Mohr’s] [added: Loeb’s] trading plan provides for the potential [added: sale of up to 4,300 shares of the Company’s common stock, including the potential] exercise and sale of up to [removed: 129,810] [added: 2,600] shares of the Company’s common stock subject to stock options, until November [removed: 15, 2024.][added: 13, 2025.]
On December [removed: 8, 2023,] [added: 12, 2024,] Bob DeSantis, the Company’s Executive Vice President and Chief Strategy and Corporate Operations Officer, adopted a Rule 10b5-1 trading plan.
Mr. DeSantis’s trading plan provides for the potential sale of up to [removed: 29,868] [added: 16,545] shares of the Company’s common stock, including the potential exercise and sale of up to [removed: 24,106] [added: 5,127] shares of the Company’s common stock subject to stock options, until December [removed: 9, 2024.][added: 12, 2025.]
[removed: Widman,] [added: Miller, Ph.D.,] the Company’s [added: Executive] Vice [removed: President, Corporate Controller,] [added: President] and [removed: Principal Accounting] [added: Chief Digital] Officer, adopted a Rule 10b5-1 trading plan.
[removed: Mr. Widman’s] [added: Dr. Miller’s] trading plan provides for the potential sale of up to [removed: 7,593] [added: 16,400] shares of the Company’s common stock, including the potential exercise and sale of up to [removed: 1,224] [added: 9,334] shares of the Company’s common stock subject to stock options, until [removed: March 7,] [added: December 10,] 2025.
On November 13, 2024, Gary H.
On December 4, 2024, David J.
On December 10, 2024, Brian E.
On December 10, 2024, Jami Dover Nachtsheim, a member of the Company’s Board of Directors, adopted a Rule 10b5-1 trading plan.
Ms. Nachtsheim’s trading plan provides for the potential exercise and sale of up to 2,400 shares of the Company’s common stock subject to stock options, until December 10, 2025.
This trading plan was entered into during an open insider trading window and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended, and the Company’s policies regarding transactions in the Company’s securities.
On November 8, 2023, David J.
On November 15, 2023, Marshall L.
On December 15, 2023, Frederik C.
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
1 rewritten, 0 added, 0 removed, 2 unchanged
Certain information required by Part III is omitted from this report on Form 10-K and is incorporated herein by reference to our definitive Proxy Statement for our next Annual Meeting of Stockholders (the “Proxy Statement”), which we intend to file pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, within 120 days after December 31, [removed: 2023.][added: 2024.]
Item 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
0 rewritten, 2 added, 0 removed, 3 unchanged
We have adopted an insider trading policy governing the purchase, sale and other dispositions of our securities by our directors, officers and employees that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, and any applicable listing standards.
A copy of our insider trading policy is filed as Exhibit 19 to this Annual Report.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item regarding security ownership of certain beneficial owners and management is incorporated by reference to the information set forth in the section titled “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in our Proxy Statement for the [removed: 2024] [added: 2025] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2023.][added: 2024.]
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULE
25 rewritten, 5 added, 3 removed, 54 unchanged
2)The following financial statement schedule of Intuitive Surgical, Inc. for [added: 2024,] 2023, [removed: 2022,] and [removed: 2021] [added: 2022] is filed as part of this report and should be read in conjunction with the Consolidated Financial Statements of Intuitive Surgical, Inc.:
| [Schedule II - Valuation and Qualifying [removed: Accounts](#idedd11384ae3443fb7ca452b61ce97d8_277)] [added: Accounts](#i4ebfb7d693504e7ea6b45dad3395a031_286)] | | | [removed: [125](#idedd11384ae3443fb7ca452b61ce97d8_277)] [added: [124](#i4ebfb7d693504e7ea6b45dad3395a031_286)] | | |
| 4.1(4) | | | | | | [Specimen Stock [removed: Certificate.](http://www.sec.gov/Archives/edgar/data/1035267/000089161800002457/0000891618-00-002457.txt)] [added: Certificate.](https://www.sec.gov/Archives/edgar/data/1035267/000089161800002457/0000891618-00-002457.txt)] | | |
| 10.1(6) | | | | | | [2000 Non-Employee Directors’ Stock Option [removed: Plan.](http://www.sec.gov/Archives/edgar/data/1035267/000089161800001640/0000891618-00-001640.txt) *] [added: Plan.](https://www.sec.gov/Archives/edgar/data/1035267/000089161800001640/0000891618-00-001640.txt)*] | | |
| 10.2(7) | | | | | | [Form of Indemnity [removed: Agreement.](http://www.sec.gov/Archives/edgar/data/1035267/000103526715000087/ex101intuitivesurgicalincf.htm) *] [added: Agreement.](https://www.sec.gov/Archives/edgar/data/1035267/000103526715000087/ex101intuitivesurgicalincf.htm)*] | | |
| 10.3(8) | | | | | | [2009 Employment Commencement Incentive Plan, as amended and [removed: restated.](http://www.sec.gov/Archives/edgar/data/1035267/000103526715000051/ex422009employmentcommence.htm) *] [added: restated.](https://www.sec.gov/Archives/edgar/data/1035267/000103526715000051/ex422009employmentcommence.htm)*] | | |
| 10.4(9) | | | | | | [2000 Employee Stock Purchase Plan, as amended and [removed: restated.](http://www.sec.gov/Archives/edgar/data/1035267/000103526717000079/ex1012000employeestockpurc.htm) *] [added: restated.](https://www.sec.gov/ix?doc=/Archives/edgar/data/0001035267/000103526724000171/isrg-20240425.htm)*] | | |
| 10.5(10) | | | | | | [2010 Incentive Award Plan, as amended and [removed: restated.](https://www.sec.gov/Archives/edgar/data/1035267/000103526722000115/ex-101xamendedandrestated2.htm) *] [added: restated.](https://www.sec.gov/ix?doc=/Archives/edgar/data/0001035267/000103526724000171/isrg-20240425.htm)*] | | |
| 10.6(11) | | | | | | [Severance [removed: Plan.](http://www.sec.gov/Archives/edgar/data/1035267/000119312508246630/dex101.htm) *] [added: Plan.](https://www.sec.gov/Archives/edgar/data/1035267/000119312508246630/dex101.htm)*] | | |
| 10.7(12) | | | | | | [Form of Amended and Restated Intuitive Surgical, Inc. 2009 Employment Commencement Incentive Plan Stock Option Grant [removed: Notice.](http://www.sec.gov/Archives/edgar/data/1035267/000103526716000130/isrg-20151231xex109.htm) *] [added: Notice.](https://www.sec.gov/Archives/edgar/data/1035267/000103526715000051/ex422009employmentcommence.htm)*] | | |
| [removed: 10.8(13)] [added: 10.10(14)] | | | | | | [Form of Amended and Restated Intuitive Surgical, Inc. [removed: 2009 Employment Commencement] [added: 2010] Incentive [added: Award] Plan [added: Global] Restricted Stock Unit Grant [removed: Notice.](http://www.sec.gov/Archives/edgar/data/1035267/000103526716000130/isrg-20151231xex1010.htm) *] [added: Notice.](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-1010xfy23rsuagreeme.htm)*] | | |
| [removed: 10.9(14)] [added: 10.9(13)] | | | | | | [Form of Amended and Restated Intuitive Surgical, Inc. 2010 Incentive Award Plan Global Stock Option Grant [removed: Notice.](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-109xfy23optionagree.htm) *] [added: Notice.](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-109xfy23optionagree.htm)*] | | |
| [removed: 10.10(15)] [added: 10.11(15)] | | | | | | [Form of Amended and Restated Intuitive Surgical, Inc. 2010 Incentive Award Plan Global [removed: Restricted] [added: Performance] Stock Unit Grant [removed: Notice.](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-1010xfy23rsuagreeme.htm) *] [added: Notice](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-1011xfy23psuagreeme.htm).*] | | |
| 21.1 | | | | | | [Intuitive Surgical, Inc. [removed: Subsidiaries.](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-211xsubsidiariesq4o.htm)] [added: Subsidiaries.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-211xsubsidiariesq4o.htm)] | | |
| 23.1 | | | | | | [Consent of Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-231xauditorconsentq.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-231xauditorconsentq.htm)] | | |
| 32.1 | | | | | | [Certification of Chief Executive Officer [removed: and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted] pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-3212xceoandcfocerto.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-321xceocertofsoxsec.htm)] | | |
| [removed: 97.1] [added: 97.1(16)] | | | | | | [Policy for Recovery of Erroneously Awarded Compensation](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-971xsecclawbackpoli.htm). | | |
| 101 | | | | | | The following materials from Intuitive Surgical, Inc.’s Annual Report on Form 10-K for the year ended December 31, [removed: 2023,] [added: 2024,] formatted in Inline XBRL (Inline Extensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income, (iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Stockholders’ Equity, (v) Consolidated Statements of Cash Flows, and (vi) Notes to Consolidated Financial Statements, tagged at Level I through IV. | | |
| 104 | | | | | | The cover page from Intuitive Surgical, Inc.’s Annual Report on Form 10-K for the year ended December 31, [removed: 2023,] [added: 2024,] formatted in Inline XBRL and contained in Exhibit 101. | | |
9.Incorporated by reference to Exhibit [removed: 10.1] [added: 10.2] filed with the Company’s Current Report on Form 8-K filed on April [removed: 26, 2017] [added: 30, 2024] (File No. 000-30713).
10.Incorporated by reference to Exhibit 10.1 filed with the Company’s Current Report on Form 8-K filed on [removed: May 3, 2022] [added: April 30, 2024] (File No. 000-30713).
13.Incorporated by reference to Exhibit [removed: 10.10] [added: 10.9] filed with the Company’s [removed: 2015] [added: 2022] Annual Report on Form 10-K filed on February [removed: 2, 2016] [added: 10, 2023] (File No. 000-30713).
14.Incorporated by reference to Exhibit [removed: 10.9] [added: 10.10] filed with the Company’s 2022 Annual Report on Form 10-K filed on February 10, 2023 (File No. 000-30713).
15.Incorporated by reference to Exhibit [removed: 10.10] [added: 10.11] filed with the Company’s 2022 Annual Report on Form 10-K filed on February 10, 2023 (File No. 000-30713).
16.Incorporated by reference to Exhibit [removed: 10.11] [added: 97.1] filed with the Company’s [removed: 2022] [added: 2023] Annual Report on Form 10-K filed on [removed: February 10, 2023] [added: January 31, 2024] (File No. 000-30713).
| 19 | | | | | | [I](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-19xinsidertradingpo.htm)[ntuitive Surgical, Inc. I](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-19xinsidertradingpo.htm)[nsider Trading Policy a](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-19xinsidertradingpo.htm)[nd Guidelines.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-19xinsidertradingpo.htm) | | |
| 31.1 | | | | | | [Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-311xceocertofsoxsec.htm) | | |
| 31.2 | | | | | | [Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-312xcfocertofsoxsec.htm) | | |
| 32.2 | | | | | | [Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.](https://www.sec.gov/Archives/edgar/data/1035267/000103526725000017/q424ex-322xcfocertofsoxsec.htm) | | |
| | | | | | | | | |
| 10.11(16) | | | | | | [Form of Amended and Restated Intuitive Surgical, Inc. 2010 Incentive Award Plan Global Performance Stock Unit Grant Notice](https://www.sec.gov/Archives/edgar/data/1035267/000103526723000019/q422ex-1011xfy23psuagreeme.htm). * | | |
| 31.1 | | | | | | [Certification of Principal Executive Officer.](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-311xceocertofsoxsec.htm) | | |
| 31.2 | | | | | | [Certification of Principal Financial Officer.](https://www.sec.gov/Archives/edgar/data/1035267/000103526724000021/q423ex-312xcfocertofsoxsec.htm) | | |
Item 16. FORM 10-K SUMMARY
17 rewritten, 7 added, 7 removed, 20 unchanged
| [added: | | | | | | | | |] INTUITIVE SURGICAL, INC. | | | | | | | | |
| [added: Date: | | | January 31, 2025 | | | | | |] By: | | | | | | /S/ GARY S. GUTHART | | |
| | | | | | | [added: | | | | | | | | |] Gary S. Guthart, Ph.D. Chief Executive Officer | | |
| /S/ GARY S. GUTHART | | | | | | Chief Executive Officer and Director (Principal Executive Officer) | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ JAMIE E. SAMATH | | | | | | [removed: Senior] [added: Executive] Vice [removed: President and] [added: President,] Chief Financial Officer (Principal Financial Officer) | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ FREDRIK C. WIDMAN | | | | | | Vice President, Corporate Controller (Principal Accounting Officer) | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ CRAIG H. BARRATT | | | | | | Chairman of the Board of Directors | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ JOSEPH C. BEERY | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ AMAL M. JOHNSON | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ SREELAKSHMI KOLLI | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ AMY L. LADD | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| Amy L. Ladd, [removed: Ph.D.] [added: M.D.] | | | | | | | | | | | | | | |
| /S/ KEITH R. LEONARD JR. | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ JAMI DOVER NACHTSHEIM | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| /S/ MONICA P. REED | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| Monica P. [removed: Reed] [added: Reed, M.D.] | | | | | | | | | | | | | | |
| /S/ MARK J. RUBASH | | | | | | Director | | | | | | January 31, [removed: 2024] [added: 2025] | | |
| | | | | | | | | | | | | | | | | | |
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| /S/ DAVID J. ROSA | | | | | | President and Director | | | | | | January 31, 2025 | | |
| David J. Rosa | | | | | | | | | | | | | | |
| /S/ LEWIS CHEW | | | | | | Director | | | | | | January 31, 2025 | | |
| Lewis Chew | | | | | | | | | | | | | | |
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Date: January 31, 2024
| /S/ DON R. KANIA | | | | | | Director | | | | | | January 31, 2024 | | |
| Don R. Kania, Ph.D. | | | | | | | | | | | | | | |
| /S/ ALAN J. LEVY | | | | | | Director | | | | | | January 31, 2024 | | |
| Alan J. Levy, Ph.D. | | | | | | | | | | | | | | |