Dexcom has won a clearance from the FDA for its longest-lasting continuous glucose monitor, a 15-day version of its flagship G7 sensor.
The new system, which boosts wear time up from the previous 10-day lifespan, is set to launch in the U.S. in the latter half of this year. It will be available for people with diabetes ages 18 and up.
The 15-day version is also slightly more accurate, according to the company, posting an overall mean absolute relative difference, or MARD—a measure of how often the CGM’s readings differ from blood-drawn glucose tests—of 8.0% compared to the standard G7’s 8.2%.
However, as it’s a new system with a new FDA clearance, Dexcom will have to work to once again demonstrate its compatibility with connected insulin pumps. The G7 can currently deliver blood sugar readings to Insulet’s Omnipod 5, the iLet Bionic Pancreas from Beta Bionics, and the Mobi and t:slim X2 systems from Tandem Diabetes Care. The company said it aims to have those links in place upon the 15-day product’s launch.
Dexcom previously broke the two-week barrier with its consumer-focused Stelo wearable, which launched as an over-the-counter sensor last year. The company has stated that its goal is to move all of its CGM systems onto the 15-day platform going forward.
The clearance was welcome news from the regulatory agency—sending Dexcom’s shares up as much as 7%, to above $70—after the company had received a warning letter from the FDA last month over manufacturing issues.
The agency said it found inadequate procedures for tracking changes to the CGM, as well as in the monitoring tests of the sensors during production. At the time, the company said it had already submitted responses to the FDA and was working on additional corrective actions. No products needed to be recalled, and the warning letter did not slow the ongoing review of the 15-day sensor or any other systems.