Dexcom (NSDQ:DXCM) said today that it won CE Mark approval in the European Union for its G5 continuous glucose monitor, saying it expects to have the device available in several countries there in the coming weeks.
San Diego-based Dexcom won pre-market approval from the FDA for the G5 device last month, touting it as the 1st approved CGM system to send data directly to smartphones without a separate receiver.
The G5 is designed to use a smartphone as its primary display and can send data to up to 5 follower devices. The user and followers can remotely monitor the glucose information, set alarms and receive notifications based on the data. Although it’s only approved in the U.S. for use with Apple (NSDQ:AAPL) iOS devices, Dexcom said it expects to win approval for Google (NSDQ:GOOG) Android devices early next year.
“The Dexcom G5 mobile CGM system lets users see and treat their diabetes in a whole new way – right on a smart device and without the need to perform confirmatory finger sticks for treatment decisions – it’s dynamic glucose information when you want it and where you want it,” president & CEO Kevin Sayer said in prepared remarks. “With an enhanced interface and fully mobile design, the device is changing the landscape of diabetes management, offering users greater convenience, flexibility and discretion than ever before.”
It’s been a busy time for Dexcom, which signed a co-development deal with the life sciences team at Google and spiked an agreement with Edwards Lifesciences (NYSE:EW) to develop CGM technology for use in hospitals.
Earlier this month the FDA approved a version of the t:slim insulin pump made by Tandem Diabetes Care (NSDQ:TNDM) with an integrated G4 Platinum monitor from Dexcom.