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

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 year.

Stelo is a small, wearable sensor, specifically for people with type 2 diabetes who do not use insulin. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone. Stelo features a 15-day wear based on the company’s G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.

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