FDA Clears Dexcom Stelo for Children
Analysis based on 7 articles · First reported Jun 13, 2026 · Last updated Jun 15, 2026
The clearance of Dexcom's Stelo Glucose Biosensor System for pediatric over-the-counter use is expected to positively impact the medical device market, particularly for companies specializing in diabetes management. This expansion into a younger demographic, especially those with prediabetes or type 2 diabetes not using insulin, opens up a significant new market segment for Dexcom.
The United States — Food and Drug Administration has cleared Dexcom's Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor (CGM) for children as young as 2 years old who do not use insulin. This device, previously approved for adults 18 and older in March 2024, aims to help caregivers and children understand how lifestyle choices affect glucose levels, addressing the rising rates of prediabetes and type 2 diabetes among American youth. The Stelo Glucose Biosensor System consists of a wearable biosensor that pairs with a smartphone app, measuring glucose levels every 15 minutes. While it offers significant benefits for glycemic awareness, the United States — Food and Drug Administration emphasizes it is not for individuals using insulin, those with problematic hypoglycemia, or patients on dialysis, and advises consultation with a healthcare provider before making medication adjustments.
Set up alerts, explore entity relationships, search across thousands of events, and build custom intelligence feeds.
Open Dashboard