Free Design Audit Available - Click Here for Details

Dexcom’s over-the-counter nod sets stage for broader CGM use

The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.

The Food and Drug Administration cleared the first over-the-counter continuous glucose monitor (CGM) on Wednesday, allowing people to buy a new sensor made by Dexcom without a prescription. Dexcom had initially sought to offer its new Stelo device to people with Type 2 diabetes who don’t take insulin, but the FDA expanded on that, opening the CGM to most adults who don’t take insulin. 

The broad indication clears a pathway for Dexcom to grow its CGM business, and for rival Abbott, which plans to bring a wellness-focused sensor to the U.S.

Sign up for Blog Updates