Dexcom (DXCM) 10-K risk factor changes: FY2025 vs FY2024
The 2025-12-31 10-K against the 2024-12-31 one, compared heading by heading and sentence by sentence.
All filing items863 rewritten543 added445 removed2,999 unchanged
Summary
counted, not written
- Item 1A headings could not be compared: the parser did not find an Item 1A in both filings.
- Sentence by sentence, 543 added, 445 removed, 863 rewritten and 2,999 unchanged across 1 item that differ.
Sentences by item
1 items, with every count and a link to each item that changed
| Item | Added | Removed | Rewritten | Unchanged |
|---|---|---|---|---|
| Full document | 543 | 445 | 863 | 2,999 |
Underlined words on a shaded ground are new in FY2025; struck-through words were in FY2024. Sentences that are wholly new or wholly gone are labelled rather than marked.
Full document
863 rewritten, 543 added, 445 removed, 2,999 unchanged
For the fiscal year ended December 31, [removed: 2024][added: 2025]
[removed: ][added: ]
As of June [removed: 28, 2024,] [added: 30, 2025,] the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $45.3] [added: $34.2] billion based on the closing sales price of [removed: $113.38] [added: $87.29] per share as reported on the Nasdaq Global Select Market on that date.
| Class | | | | | | Outstanding at February [removed: 6, 2025] [added: 5, 2026] | | |
| Common stock, $0.001 par value per share | | | | | | [removed: 390,772,018] [added: 384,864,842] | | |
Portions of the registrant’s definitive proxy statement relating to its [removed: 2025] [added: 2026] Annual Meeting of Stockholders (the “Proxy Statement”) are incorporated by reference in Part III, Items 10 through 14 of this Annual Report on Form 10-K, as specified in the responses to those item numbers, which proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year covered by this Form 10-K.
| [ITEM [removed: 1.](#i6a987b433ae84cbfb2328647e6586107_25)] [added: 1.](#i863d5bab53004feeb077a051d3498b26_22)] | | | [removed: [Business](#i6a987b433ae84cbfb2328647e6586107_25)] [added: [Business](#i863d5bab53004feeb077a051d3498b26_22)] | | | [removed: [6](#i6a987b433ae84cbfb2328647e6586107_25)] [added: [6](#i863d5bab53004feeb077a051d3498b26_22)] | | |
| [ITEM [removed: 1A.](#i6a987b433ae84cbfb2328647e6586107_64)] [added: 1A.](#i863d5bab53004feeb077a051d3498b26_64)] | | | [Risk [removed: Factors](#i6a987b433ae84cbfb2328647e6586107_64)] [added: Factors](#i863d5bab53004feeb077a051d3498b26_64)] | | | [removed: [27](#i6a987b433ae84cbfb2328647e6586107_64)] [added: [27](#i863d5bab53004feeb077a051d3498b26_64)] | | |
| [ITEM [removed: 1B.](#i6a987b433ae84cbfb2328647e6586107_112)] [added: 1B.](#i863d5bab53004feeb077a051d3498b26_115)] | | | [Unresolved Staff [removed: Comments](#i6a987b433ae84cbfb2328647e6586107_112)] [added: Comments](#i863d5bab53004feeb077a051d3498b26_115)] | | | [removed: [69](#i6a987b433ae84cbfb2328647e6586107_112)] [added: [71](#i863d5bab53004feeb077a051d3498b26_115)] | | |
| [ITEM [removed: 1C.](#i6a987b433ae84cbfb2328647e6586107_115)] [added: 1C.](#i863d5bab53004feeb077a051d3498b26_118)] | | | [removed: [Cybersecurity](#i6a987b433ae84cbfb2328647e6586107_115)] [added: [Cybersecurity](#i863d5bab53004feeb077a051d3498b26_118)] | | | [removed: [69](#i6a987b433ae84cbfb2328647e6586107_115)] [added: [71](#i863d5bab53004feeb077a051d3498b26_118)] | | |
| [ITEM [removed: 3.](#i6a987b433ae84cbfb2328647e6586107_121)] [added: 3.](#i863d5bab53004feeb077a051d3498b26_124)] | | | [Legal [removed: Proceedings](#i6a987b433ae84cbfb2328647e6586107_121)] [added: Proceedings](#i863d5bab53004feeb077a051d3498b26_124)] | | | [removed: [71](#i6a987b433ae84cbfb2328647e6586107_121)] [added: [73](#i863d5bab53004feeb077a051d3498b26_124)] | | |
| [ITEM [removed: 4.](#i6a987b433ae84cbfb2328647e6586107_124)] [added: 4.](#i863d5bab53004feeb077a051d3498b26_130)] | | | [Mine Safety [removed: Disclosures](#i6a987b433ae84cbfb2328647e6586107_124)] [added: Disclosures](#i863d5bab53004feeb077a051d3498b26_130)] | | | [removed: [73](#i6a987b433ae84cbfb2328647e6586107_124)] [added: [74](#i863d5bab53004feeb077a051d3498b26_130)] | | |
| [ITEM [removed: 5.](#i6a987b433ae84cbfb2328647e6586107_130)] [added: 5.](#i863d5bab53004feeb077a051d3498b26_136)] | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i6a987b433ae84cbfb2328647e6586107_130)] [added: Securities](#i863d5bab53004feeb077a051d3498b26_136)] | | | [removed: [74](#i6a987b433ae84cbfb2328647e6586107_130)] [added: [75](#i863d5bab53004feeb077a051d3498b26_136)] | | |
| [ITEM [removed: 7.](#i6a987b433ae84cbfb2328647e6586107_139)] [added: 7.](#i863d5bab53004feeb077a051d3498b26_148)] | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i6a987b433ae84cbfb2328647e6586107_139)] [added: Operations](#i863d5bab53004feeb077a051d3498b26_148)] | | | [removed: [76](#i6a987b433ae84cbfb2328647e6586107_139)] [added: [77](#i863d5bab53004feeb077a051d3498b26_148)] | | |
| [ITEM [removed: 7A.](#i6a987b433ae84cbfb2328647e6586107_163)] [added: 7A.](#i863d5bab53004feeb077a051d3498b26_178)] | | | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#i6a987b433ae84cbfb2328647e6586107_163)] [added: Risk](#i863d5bab53004feeb077a051d3498b26_178)] | | | [removed: [87](#i6a987b433ae84cbfb2328647e6586107_163)] [added: [87](#i863d5bab53004feeb077a051d3498b26_178)] | | |
| [ITEM [removed: 8.](#i6a987b433ae84cbfb2328647e6586107_175)] [added: 8.](#i863d5bab53004feeb077a051d3498b26_190)] | | | [Financial Statements and Supplementary [removed: Data](#i6a987b433ae84cbfb2328647e6586107_175)] [added: Data](#i863d5bab53004feeb077a051d3498b26_190)] | | | [removed: [88](#i6a987b433ae84cbfb2328647e6586107_175)] [added: [88](#i863d5bab53004feeb077a051d3498b26_190)] | | |
| [ITEM [removed: 9.](#i6a987b433ae84cbfb2328647e6586107_178)] [added: 9.](#i863d5bab53004feeb077a051d3498b26_193)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i6a987b433ae84cbfb2328647e6586107_178)] [added: Disclosure](#i863d5bab53004feeb077a051d3498b26_193)] | | | [removed: [88](#i6a987b433ae84cbfb2328647e6586107_178)] [added: [88](#i863d5bab53004feeb077a051d3498b26_193)] | | |
| [ITEM [removed: 9A.](#i6a987b433ae84cbfb2328647e6586107_181)] [added: 9A.](#i863d5bab53004feeb077a051d3498b26_196)] | | | [Controls and [removed: Procedures](#i6a987b433ae84cbfb2328647e6586107_181)] [added: Procedures](#i863d5bab53004feeb077a051d3498b26_196)] | | | [removed: [89](#i6a987b433ae84cbfb2328647e6586107_181)] [added: [89](#i863d5bab53004feeb077a051d3498b26_196)] | | |
| [ITEM [removed: 9B.](#i6a987b433ae84cbfb2328647e6586107_187)] [added: 9B.](#i863d5bab53004feeb077a051d3498b26_202)] | | | [Other [removed: Information](#i6a987b433ae84cbfb2328647e6586107_187)] [added: Information](#i863d5bab53004feeb077a051d3498b26_202)] | | | [removed: [91](#i6a987b433ae84cbfb2328647e6586107_187)] [added: [91](#i863d5bab53004feeb077a051d3498b26_202)] | | |
| [ITEM [removed: 9C.](#i6a987b433ae84cbfb2328647e6586107_193)] [added: 9C.](#i863d5bab53004feeb077a051d3498b26_214)] | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i6a987b433ae84cbfb2328647e6586107_193)] [added: Inspections](#i863d5bab53004feeb077a051d3498b26_214)] | | | [removed: [91](#i6a987b433ae84cbfb2328647e6586107_193)] [added: [91](#i863d5bab53004feeb077a051d3498b26_214)] | | |
| [ITEM [removed: 10.](#i6a987b433ae84cbfb2328647e6586107_199)] [added: 10.](#i863d5bab53004feeb077a051d3498b26_220)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i6a987b433ae84cbfb2328647e6586107_199)] [added: Governance](#i863d5bab53004feeb077a051d3498b26_220)] | | | [removed: [92](#i6a987b433ae84cbfb2328647e6586107_199)] [added: [92](#i863d5bab53004feeb077a051d3498b26_220)] | | |
| [ITEM [removed: 11.](#i6a987b433ae84cbfb2328647e6586107_202)] [added: 11.](#i863d5bab53004feeb077a051d3498b26_223)] | | | [Executive [removed: Compensation](#i6a987b433ae84cbfb2328647e6586107_202)] [added: Compensation](#i863d5bab53004feeb077a051d3498b26_223)] | | | [removed: [92](#i6a987b433ae84cbfb2328647e6586107_202)] [added: [92](#i863d5bab53004feeb077a051d3498b26_223)] | | |
| [ITEM [removed: 12.](#i6a987b433ae84cbfb2328647e6586107_205)] [added: 12.](#i863d5bab53004feeb077a051d3498b26_226)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i6a987b433ae84cbfb2328647e6586107_205)] [added: Matters](#i863d5bab53004feeb077a051d3498b26_226)] | | | [removed: [92](#i6a987b433ae84cbfb2328647e6586107_205)] [added: [92](#i863d5bab53004feeb077a051d3498b26_226)] | | |
| [ITEM [removed: 13.](#i6a987b433ae84cbfb2328647e6586107_208)] [added: 13.](#i863d5bab53004feeb077a051d3498b26_229)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i6a987b433ae84cbfb2328647e6586107_208)] [added: Independence](#i863d5bab53004feeb077a051d3498b26_229)] | | | [removed: [92](#i6a987b433ae84cbfb2328647e6586107_208)] [added: [92](#i863d5bab53004feeb077a051d3498b26_229)] | | |
| [ITEM [removed: 14.](#i6a987b433ae84cbfb2328647e6586107_211)] [added: 14.](#i863d5bab53004feeb077a051d3498b26_232)] | | | [Principal Accountant Fees and [removed: Services](#i6a987b433ae84cbfb2328647e6586107_211)] [added: Services](#i863d5bab53004feeb077a051d3498b26_232)] | | | [removed: [93](#i6a987b433ae84cbfb2328647e6586107_211)] [added: [93](#i863d5bab53004feeb077a051d3498b26_232)] | | |
| [ITEM [removed: 15.](#i6a987b433ae84cbfb2328647e6586107_217)] [added: 15.](#i863d5bab53004feeb077a051d3498b26_238)] | | | [removed: [Exhibits](#i6a987b433ae84cbfb2328647e6586107_217)] [added: [Exhibits](#i863d5bab53004feeb077a051d3498b26_238)] and [Financial Statement [removed: Schedules](#i6a987b433ae84cbfb2328647e6586107_217)] [added: Schedules](#i863d5bab53004feeb077a051d3498b26_238)] | | | [removed: [94](#i6a987b433ae84cbfb2328647e6586107_217)] [added: [94](#i863d5bab53004feeb077a051d3498b26_238)] | | |
| [ITEM [removed: 16.](#i6a987b433ae84cbfb2328647e6586107_220)] [added: 16.](#i863d5bab53004feeb077a051d3498b26_241)] | | | [Form 10-K [removed: Summary](#i6a987b433ae84cbfb2328647e6586107_220)] [added: Summary](#i863d5bab53004feeb077a051d3498b26_241)] | | | [removed: [96](#i6a987b433ae84cbfb2328647e6586107_220)] [added: [96](#i863d5bab53004feeb077a051d3498b26_241)] | | |
Our website address is located at [removed: dexcom.com] [added: www.dexcom.com] and our investor relations website is located at investors.dexcom.com.
[removed: - We are subject to risks associated with public health issues, including pandemics, which] [added: Any of these events] could have a material adverse effect on our business, financial condition and results of operations.
We launched our latest generation systems, the Dexcom [removed: G6 integrated] [added: G7] Continuous Glucose Monitoring System, or [removed: G6,] [added: G7,] in [removed: 2018,] [added: 2023,] and [removed: we launched] the Dexcom [removed: G7,] [added: G7 15 Day Continuous Glucose Monitoring System,] or [removed: G7,] [added: G7 15 Day,] in [removed: 2023.][added: late 2025.]
In August 2024, we launched Stelo, our [removed: new] biosensor designed for adults with prediabetes and Type 2 diabetes who do not use insulin, as the first over-the-counter glucose biosensor in the U.S.
*Dexcom [removed: G7*][added: ONE+*]
Like the [removed: G6,] [added: G7,] the G7 [added: 15 Day] is an [removed: integrated continuous glucose monitoring system, or iCGM, and is] [added: iCGM] classified as a Class II device by the FDA, and is subject to [added: iCGM] special controls.
The glucose value algorithm, ability to communicate with approved display and mobile devices, and compatibility with Dexcom Clarity, our cloud-based reporting software, are all substantially equivalent in technical performance and capability to the [added: prior generation Dexcom G6 Continuous Glucose Monitoring Integrated System, or] G6.
[removed: Dexcom] [added: The] G7 is cleared in the United States for all people with diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution.
With an overall Mean Absolute Relative Difference, or MARD, of [removed: 8.2%,] [added: 8.0%,] as well as [removed: 94.1%] [added: 94.2%] of values within 20% of their comparator, [removed: Dexcom] [added: the] G7 [added: 15 Day] is the most accurate CGM cleared by the FDA and is clinically proven to lower A1C (a blood test that provides information about average levels of blood glucose, over the prior three months), reduce hyper- and hypoglycemia, and increase time in range.
The G7 [removed: carries] [added: and G7 15 Day carry] forward important features of prior generation Dexcom CGM systems:
The G7 [added: and G7 15 Day] also [removed: has] [added: have] a number of new or improved features compared to our prior generation devices:
- Faster warm up. 30-minute sensor warm [removed: up,] [added: up for the G7,] fastest of any CGM on the [removed: market.][added: market, and 60-minute sensor warm up for the G7 15 Day.]
- New indications for use. [removed: Indicated] [added: For the G7, indicated] in the United States for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-6 years old.
| [PART I](#i863d5bab53004feeb077a051d3498b26_22) | | | | | | | | |
| [ITEM 2.](#i863d5bab53004feeb077a051d3498b26_121) | | | [Properties](#i863d5bab53004feeb077a051d3498b26_121) | | | [73](#i863d5bab53004feeb077a051d3498b26_121) | | |
| [PART II](#i863d5bab53004feeb077a051d3498b26_133) | | | | | | | | |
| [ITEM 6.](#i863d5bab53004feeb077a051d3498b26_145) | | | [\[Reserved\]](#i863d5bab53004feeb077a051d3498b26_145) | | | [76](#i863d5bab53004feeb077a051d3498b26_145) | | |
| [PART III](#i863d5bab53004feeb077a051d3498b26_217) | | | | | | | | |
| [PART IV](#i863d5bab53004feeb077a051d3498b26_235) | | | | | | | | |
| | | | [Signatures](#i863d5bab53004feeb077a051d3498b26_244) | | | [97](#i863d5bab53004feeb077a051d3498b26_244) | | |
“Dexcom”, “Dexcom Clarity”, “Dexcom Follow”, “Dexcom One”, “Dexcom ONE+” “Dexcom Share”, “Stelo”, and any related logos and design marks appearing in this Annual Report on Form 10-K are either registered trademarks or trademarks of DexCom, Inc. in the United States and/or other countries.
*Dexcom G7 and G7 15 Day*
In April 2025, we obtained marketing authorization from the FDA for the G7 15 Day via the 510(k) review process for people over the age of 18 with diabetes in the United States.
G7 15 Day will also be covered for Medicare beneficiaries and has met the category requirements for therapeutic CGM systems set forth by the U.S. Centers for Medicare & Medicaid Services, or CMS.
- Extended 15.5 day disposable sensor and 10-day disposable sensor, for the G7 15 Day and G7, respectively.
We anticipate transitioning our G6 customers to our G7 and G7 15 Day sensor systems by the end of 2026.
Our previous generation Dexcom ONE CGM system, with similar features as G6, is anticipated to be phased out by the end of 2026.
In August 2024, we launched Stelo, our biosensor designed for adults with prediabetes and Type 2 diabetes who do not use insulin, as the first over-the-counter glucose biosensor in the U.S. By virtue of not requiring a prescription, Stelo expands access to CGM beyond people with diabetes to include those seeking to optimize metabolic health to more effectively and conveniently manage their glucose levels.
information to the cloud and then to apps on the mobile devices of up to ten designated recipients, or “followers,” who can remotely monitor a patient’s glucose information and receive alert notifications anywhere they have a wireless connection via the Dexcom Follow app.
Such competitors may benefit from guidance issued on January 6, 2026 by the FDA’s Center for Devices and Radiological Health that effectively broadens the range of products that may be considered “general wellness devices,” including wearables that provide readings around bodily functions and vital signs such as heart rate, blood pressure, and blood glucose.
We primarily manufacture our products at our manufacturing facilities in Mesa, Arizona and Penang, Malaysia.
For example, in March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona relating to observed non-conformities in manufacturing
processes and our quality management system.
See the section of the Risk Factors entitled “*Risks Related to Manufacturing, Commercial Operations and Commercialization*” and “*If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, including responding to the FDA warning letter, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.*”
In late 2025, CMS extended the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program to include our CGMs and receivers beginning with contracting in 2027, and payment changes effective January 1, 2028.
Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items.
CMS anticipates that ten (10) contracts will be awarded for CGMs.
However, while the competitive bidding program previously used competitive bidding areas, or CBAs, for contract awards, CMS determined that for CGMs and certain other DME, a Remote Item Delivery, or RID, CBA was more appropriate.
It remains to be seen whether CGMs will be covered under a single, nationwide RID CBA or whether regional RID CBAs will be established.
In any event, the bid process is expected to result in lower Medicare reimbursement for CGM systems, particularly because CMS is changing the pricing under the RID CBA by setting a single payment amount for covered items at the 75th percentile of the winning bids, rather than using the maximum winning bid.
Further, CMS has reclassified CGMs and insulin infusion pumps to items that require frequent and substantial servicing and will phase in monthly rental payments for these items.
CMS will bundle the rental amount for the receiver device with payment for the supplies and accessories in the new payment amount.
Beneficiaries who own their CGMs or insulin infusion pumps may either continue to use them until replacement is necessary or immediately switch to a rental item.
The bid limit will be monthly fee schedule amounts for the supplies plus the average purchase fee schedule amounts for the CGM receiver device divided by 60 (intended to capture the 5-year useful life of the device).
As a result, we expect that Medicare reimbursement for our CGM systems will decrease beginning in 2028.
CMS is required by law to recompete these contracts at least once every three years and to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas to match competitive bidding prices.
The implementation of the competitive bidding program may result in reduced Medicare payment for CGMs in both competitive bidding areas and non-competitive bidding areas.
Our Board of Directors has delegated responsibility to our Nominating and Governance Committee for the oversight of sustainability matters.
Additionally, the Corporate Sustainability Steering Committee, consisting of members of senior management from Legal, Finance, Human Resources, Commercial and Operations, is responsible for establishing programs, policies and practices relating to sustainability matters, under the auspice of the Nominating and Governance Committee.
The QMSR amends the quality regulations to align more closely with international consensus standards for quality management systems for medical devices used by other regulatory authorities around the world.
Some devices are placed in Class III, which requires approval of a PMA application and may require human clinical trials, if they are deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices,
In March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona.
In the warning letter, the FDA cited deficiencies in the response letters sent by us to the FDA following the Form 483, List of Investigational Observations that was delivered to us in connection with the inspection of our San Diego, California facility that occurred from October 2024 through November 2024, and the inspection of our Mesa, Arizona facility that occurred in June 2024.
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| [PART I](#i6a987b433ae84cbfb2328647e6586107_25) | | | | | | | | |
| [ITEM 2.](#i6a987b433ae84cbfb2328647e6586107_118) | | | [Properties](#i6a987b433ae84cbfb2328647e6586107_118) | | | [71](#i6a987b433ae84cbfb2328647e6586107_118) | | |
| [PART II](#i6a987b433ae84cbfb2328647e6586107_127) | | | | | | | | |
| [ITEM 6.](#i6a987b433ae84cbfb2328647e6586107_133) | | | [\[Reserved\]](#i6a987b433ae84cbfb2328647e6586107_133) | | | [75](#i6a987b433ae84cbfb2328647e6586107_133) | | |
| [PART III](#i6a987b433ae84cbfb2328647e6586107_196) | | | | | | | | |
| [PART IV](#i6a987b433ae84cbfb2328647e6586107_214) | | | | | | | | |
| | | | [Signatures](#i6a987b433ae84cbfb2328647e6586107_223) | | | [97](#i6a987b433ae84cbfb2328647e6586107_223) | | |
“Dexcom”, “Dexcom Clarity”, and “Dexcom One”, and other trademarks of ours appearing in this report are our property.
- Finger stick elimination. No finger sticks are needed for calibration or diabetes treatment decisions, consistent with the instructions for use, unless symptoms do not match readings.
- Continuous glucose readings. Automatically sends glucose readings to a Dexcom receiver or compatible display device every five minutes.
- Mobile app and sharing. Compatibility with mobile device applications allows for sharing glucose information with up to 10 other people for added support and care coordination.
- Customizable alarms and alerts. Personalized alert schedule immediately warns the user of pending dangerous high and low blood sugar levels.
- Easy sensor application. Complete redesign of the sensor applicator allows for one-touch, simple self-insertion.
- Predictive low alert. Alert feature intended to predict hypoglycemia before it hits to help avoid dangerous low blood sugar events.
- Extended 10-day disposable sensor.
G6 and substantially equivalent devices of this generic type that may later receive marketing authorization are referred to as integrated continuous glucose monitoring systems, or iCGMs, and have been classified as Class II devices by the FDA.
The G6 is designed to automatically transfer data from the transmitter to the Dexcom receiver device as well as allow our transmitter to run an algorithm to generate a glucose value and to communicate directly to a patient’s compatible mobile device, including iPhone®, iPod touch®, iPad®, and certain Android® mobile devices.
A patient’s glucose data can also be displayed on wearable devices, like the Apple Watch® and Wear OS by Google devices.
The G6 transmitter has a labeled useful life of three months.
Data from the G6 can be integrated with Dexcom Clarity, our cloud-based reporting software, for personalized, easy-to-understand analysis of trends that may improve diabetes management.
In the United States, the G6 is covered by Medicare and Medicaid in the majority of states and by commercial insurers, subject to satisfaction of certain eligibility and coverage criteria for individuals with both Type 1 and Type 2 diabetes.
In October 2019, we also received marketing authorization from the FDA for the Dexcom G6 Pro, or G6 Pro, which allows healthcare professionals to purchase the G6 for use by their patients.
The G6 Pro has many of same features as the G6 and is intended for healthcare professionals to use with their patients ages two years and up.
The G6 Pro may be used in a blinded or unblinded mode for up to 10 days.
For the G6, the sensor is inserted by the user and is intended to be used continuously for up to 10 days, after which it may be replaced with a new disposable sensor.
Our transmitter is reusable until it reaches the end of its use life, labeled as three months.
Our receiver is also reusable.
As we continue to establish an installed base of customers using our products, we expect to generate an increasing portion of our revenues through recurring sales of our disposable sensors.
The G6 carries forward important features of prior generation Dexcom CGM systems:
- Integration with the world’s largest connected CGM ecosystem (including Apple Watch, Garmin and other digital health apps).
The G6 also has a number of new or improved features compared to our prior generation devices:
- Discreet and low profile. A redesigned transmitter with a 28% lower profile than the previous generation Dexcom CGM system makes the device comfortable and easy to wear under clothing.
- Medication blocking. Allows for more accurate glucose readings without interference from common medications taken at typical indication doses, such as acetaminophen.
- Extended 10-day disposable sensor. Up to 10-day sensor use allows for 43% longer wear than previous generation Dexcom CGM systems.
Since the G6 is classified by the FDA as a Class II device, it is subject to special controls and modifications of, or revisions to, the device may be made under the 510(k) process.
*Dexcom ONE*
An excerpt. Shown here: 40 of 863 rewritten, 40 of 543 added and 40 of 445 removed. The counts are complete. For every sentence, read Full document in the FY2025 filing and the FY2024 filing.