Dexcom (Nasdaq:DXCM) announced today that it received CE mark approval in Europe for its G7 continuous glucose monitoring (CGM) system.
The San Diego–based company has also submitted for an FDA 510(k) for G7 and awaits clearance in the U.S.
Dexcom designed its next-generation CGM offering as an all-in-one wearable system. It warms up in 30 minutes — compared to two hours with the previous G6 generation — and sends real-time glucose readings automatically to a compatible smart device or receiver with no fingersticks required.
The Dexcom G7 system comes in at a smaller size with fewer components and improved ease of use compared to G6, while it also demonstrates high accuracy in the hypoglycemic range across a range of ages and body mass indexes (BMIs).
Regulatory approval in Europe covers the use of the next-generation G7 CGM for people with diabetes aged two years and older, including pregnant women. Dexcom expects to launch the G7 in Europe in the coming weeks and also plans to introduce an updated CGM algorithm in 2022 ahead of what President and CEO Kevin Sayer said will be a year full of activity.
“Today marks an incredible milestone for our company and for people with diabetes in Europe,” Sayer said in a news release. “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.”
In addition to the reduced warm-up time, G7 is also 60% smaller than G6 as an all-in-one, discreet wearable developed in partnership with Google’s life science sister company Verily. The device also has a 12-hour grace period for replacing finished sensors, a redesigned and simplified mobile app and improved alert settings for enhanced discretion.
Dexcom’s G7 has a redesigned optional receiver that is smaller than previous versions to provide a more vibrant, easier-to-read display. With an anticipated software release in the future, readings will go direct to Apple Watch, too.
The system maintains features G6 users will already be comfortable with, including no fingersticks, scanning or calibration with the real-time glucose readings sent automatically to a compatible device. G7 remains indicated for wear on the back of the upper arm and abdomen for ages 2 and older or on the upper buttocks for ages 2-17.
Dexcom said it is working closely with its insulin pump partners to integrate the G7 system 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,” Professor Partha S. Kar, OBE, national specialty advisor, Diabetes at NHS England and consultant endocrinologist at Portsmouth Hospitals NHS Trust, said in the release. “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.”
BTIG analyst Marie Thibault reaffirmed Dexcom’s status as a “Buy” after the news, highlighting the improvements as a reason that Dexcom will compete “more effectively,” especially in the type 2 diabetes market, while overall CGM awareness and adoption in Europe could increase with the G7 launch and Abbott’s expansion of the Freestyle Libre 3 into Germany, the U.K. and France.
“We think improved pricing, reimbursement coverage, and accessibility remain crucial to overall market expansion for all players,” the analyst wrote. “We expect DXCM shares to trade higher today on the announcement. We are not making any changes to our forecast, as the clearance timing is relatively in line with expectations.”
DXCM shares were up more than 5% at $413.35 apiece in morning trading today. MassDevice and DDBN‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1%.