Dexcom G7 Receives CE Mark – Next-Generation Continuous Glucose Monitoring System to Revolutionize Diabetes Management

Rhea-AI Summary

Dexcom announced CE Mark approval for its G7 Continuous Glucose Monitoring (CGM) System, enhancing diabetes management for users in Europe aged two years and older, including pregnant women. The G7 is designed to be more powerful and user-friendly, with a 30-minute sensor warmup time, no fingersticks required, and real-time glucose readings sent to compatible devices. The system reduces blood sugar fluctuations and increases time in range, supporting better health outcomes.

Positive

• CE Mark approval for Dexcom G7 allows for sales in Europe.
• 30-minute sensor warmup is the fastest on the market.
• User-friendly features promote better diabetes management.

Negative

• None.

• The best-selling real-time CGM in the world¹ is now more powerful and easier to use with a small, all-in-one wearable and completely redesigned mobile app
• New system has the fastest sensor warmup on the market,* with no fingersticks^† or scanning required
• Dexcom G7 builds on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range^2,3

EDINBURGH, Scotland & SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today it has secured CE Mark (Conformité Européenne) for the Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with diabetes in Europe age two years and older, including pregnant women.

With Dexcom G7, real-time glucose readings are sent automatically to a compatible display device. (Photo: Business Wire)

Dexcom G7 offers a better way to help users gain greater control of their diabetes, so that they can manage it more confidently each day. Its low-profile, all-in-one wearable warms up faster than any other CGM on the market,^* sending real-time glucose readings automatically to a compatible smart device^‡ or receiver, no fingersticks required.^† Dexcom G7 also offers a suite of customizable alerts that can warn of high or low glucose levels and help users spend more time in range.^§,2 Industry-leading remote monitoring and reporting capabilities also allow users to stay connected with their loved ones and care teams anytime, anywhere.^||

“Today marks an incredible milestone for our company and for people with diabetes in Europe,” said Kevin Sayer, chairman, president and CEO of Dexcom. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better.”

New features with Dexcom G7: 60 percent smaller, all-in-one, discreet wearable, developed in partnership with Verily 30-minute sensor warm up, fastest of any CGM on the market* 12-hour grace period to replace finished sensors for a more seamless transition between sessions Redesigned and simplified mobile app with Dexcom Clarity integration#,** Improved alert settings for enhanced discretion Redesigned optional receiver that is smaller, with a more vibrant, easier to read display Direct to Apple Watch (anticipated future software release)

Dexcom G6 features included with Dexcom G7: No fingersticks†, scanning or calibration Real-time glucose readings sent automatically to a compatible display device‡ Indicated for wear on the back of the upper arm and abdomen for ages 2 years and older or the upper buttocks for ages 2-17 years old Integration with the world’s largest connected CGM ecosystem Remote monitoring, enabling users to share glucose data with up to 10 followers|| Proven Dexcom accuracy and performance4

Dexcom is also working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.

“Over the past 20 years, Dexcom has been one of the leaders and pioneers in advancing real-time CGM technology,” said Professor Partha S. Kar, OBE, national specialty advisor, Diabetes at NHS England and consultant endocrinologist at Portsmouth Hospitals NHS Trust. “With enhanced features and added simplicity, Dexcom G7 will hopefully make diabetes management easier for both patients and their healthcare providers, something that is especially important as we see more and more evidence of the benefits of CGM in broader populations of those living with diabetes.”

Dexcom expects to initiate a launch of Dexcom G7 in Europe in the next several weeks. The company also plans to introduce an updated CGM algorithm in 2022, driving the next step forward in CGM sensor performance.

Visit Dexcom.com and get started with Dexcom G6 today to experience the benefits of CGM now. To learn more about Dexcom G7 and for additional information about when it will be available in Europe, visit Dexcom.com/G7.

Dexcom submitted a comprehensive 510(k) pre-market notification to the U.S. Food and Drug Administration for regulatory review of the Dexcom G7 CGM System in accordance with the iCGM Special Controls in Q4 2021.^††

About DexCom, Inc.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, and with operations across Europe, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements that are not purely historical regarding Dexcom’s or its management’s intentions, beliefs, expectations and strategies for the future, including statements with respect to timing of the G7 launch in Europe, updates to its CGM algorithm and impacts to diabetes management. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Dexcom, deal with future events, are subject to various risks and uncertainties, including risks and uncertainties relating to our development, preparation, and potential future submission of a 510(k) application for G7 to the US FDA and the potential timing or results of regulatory review of such an application, and actual results could differ materially from those anticipated in those forward-looking statements. The risks and uncertainties that may cause actual results to differ materially from Dexcom’s current expectations are more fully described in Dexcom’s Quarterly Report on Form 10-Q for the period ended September 30, 2021, as filed with the Securities and Exchange Commission on October 28, 2021. Except as required by law, Dexcom assumes no obligation to update any such forward-looking statement after the date of this report or to conform these forward-looking statements to actual results.

^*Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.
^†If your glucose alerts and readings from Dexcom G7 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.
^‡To view a list of compatible smart devices, visit dexcom.com/compatibility
^§Results obtained with a prior generation Dexcom CGM System.
^||Separate Dexcom Follow app and internet connection required. Internet connectivity required for data sharing. Users should always confirm readings on the Dexcom G7 app or receiver before making treatment decisions.
Compared to a prior generation Dexcom CGM System.
^#Healthcare providers can register for Dexcom Clarity at clarity.dexcom.com/professional/ registration.
^**An internet connection is required for patients to send their glucose data to Dexcom Clarity via a compatible smart device: dexcom.com/compatibility. Healthcare providers will only be able to view a patient’s glucose data if the patient elects to share it with them through Dexcom Clarity.
^††Pending 510(k) clearance -- Not available for sale in the U.S.

1 Dexcom, data on file, 2021
2 Beck RW, et al. JAMA. 2017;317(4):371-378.
3 Welsh JB, et al. Diabetes Technol Ther. 2019;21(3):128-132.
4 Dexcom G7 User Guide.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220309005998/en/

Media Contact

James McIntosh

619-884-2118

james.mcintosh@dexcom.com

Investor Contact

Sean Christensen

858-203-6657

sean.christensen@dexcom.com

Source: DexCom, Inc.

FAQ

What is the significance of the CE Mark for Dexcom G7?

The CE Mark approval allows Dexcom to market and sell the G7 Continuous Glucose Monitoring System in Europe, expanding its user base.

What are the key features of the Dexcom G7 CGM system?

The Dexcom G7 features a 30-minute sensor warmup, no fingersticks, real-time glucose readings, and customizable alerts for glucose levels.

How does the Dexcom G7 improve diabetes management?

The G7 provides rapid glucose monitoring and alerts, helping users maintain better control of their diabetes and spend more time in the target range.

When will the Dexcom G7 be launched in Europe?

The launch of the Dexcom G7 in Europe is expected to initiate in the coming weeks.