Dexcom (NSDQ:DXCM) won CE Mark clearance today in the European Union for its G6 continuous glucose monitoring system.
The G6 system, which won approval in the U.S. as ‘fully interoperable’ with other medical devices, includes a redesigned applicator that inserts a small sensor below the user’s skin. The sensor measures glucose levels and sends the data to a display device via a transmitter, which can be worn for up to 10 days.
The next-gen transmitter has a 28% lower profile than the G5 system, according to Dexcom, to provide patients with a more comfortable option to wear throughout the day.
The monitor also warns users if their blood sugar levels climb dangerously high or fall below the desired range.
“The Dexcom G6 represents the future of diabetes management. Not only does the product eliminate the need for fingersticks, but it also maintains the performance, connectivity and accuracy that the diabetes community has come to expect from Dexcom CGM,” John Lister, Dexcom’s GM for EMEA, said in prepared remarks.
“We’re treading new ground,” CEO Kevin Sayer told Drug Delivery Business News earlier this year.
The company said the G6 will be available this month in the U.K. and Ireland. Other European countries can expect to see the product later this year.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.