EDINBURGH, March 15 – 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.
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. 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 Verily30-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 sessionsRedesigned and simplified mobile app with Dexcom Clarity integration#,**Improved alert settings for enhanced discretionRedesigned optional receiver that is smaller, with a more vibrant, easier to read displayDirect to Apple Watch (anticipated future software release) | Dexcom G6 features included with Dexcom G7:No fingersticks†, scanning or calibrationReal-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 oldIntegration with the world’s largest connected CGM ecosystemRemote 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.
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.
