FDA Approves Dexcom's Pediatric Continuous Glucose Monitor for Sale
The U.S. Food and Drug Administration cleared for marketing the first over-the-counter continuous glucose monitor for children, Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated CGM indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. "Children deserve access to the best tools available to manage their health," said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. "Today's clearance reflects the FDA's commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play."
