FDA Clears First OTC Continuous Glucose Monitor for Kids

The FDA Just Cleared the First OTC Continuous Glucose Monitor for Children

Stelo can now be marketed for children 2 years of age and older who do not use insulin.

FDA Clears First OTC Continuous Glucose Monitor for Kids

(MedPage Today) -- The FDA cleared the first over-the-counter (OTC) integrated continuous glucose monitor (CGM) for children 2 years and older with or without diabetes, the agency announced on Friday. The Stelo Glucose Biosensor System device...

In a first, Dexcom’s OTC glucose sensor is cleared for kids

The Stelo over-the-counter glucose monitor can now be used by children as young as two years.

FDA Expands OTC Glucose Monitor Access to Children

WASHINGTON, D.C. — The U.S. Food and Drug Administration has cleared the first over-the-counter continuous glucose monitor for children, expanding access to glucose-tracking technology as rates of prediabetes and Type 2 diabetes rise among younger Americans. The agency authorized use of the Stelo Glucose Biosensor System, manufactured by Dexcom, for children ages 2 and older who do not use insulin. The device was previously cleared for over-the-…

FDA clears Dexcom Stelo over-the-counter CGM for children

The Stelo OTC CGM [Image courtesy of Dexcom]Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children. The FDA said in a news release that it cleared Stelo for people two years of age and older who do not use insulin. It became the first OTC CGM system granted clearance in March 2024, initially getting the green light for people ages 18 and older. Stelo launched later that …