June 12, 2026
1 min read
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FDA clears OTC CGM for children aged 2 years and older who do not use insulin
The FDA has announced additional marketing clearance for the Dexcom Stelo Glucose Biosensor System for children aged 2 years and older, according to a press release.The Dexcom Stelo Glucose Biosensor System received FDA marketing clearance for adults in March 2024. The clearance now extends to children aged 2 years and older.
TL;DRAI
FDA clears Dexcom Stelo OTC continuous glucose monitor for children 2+ years; wearable updates glucose data every 15 minutes via app. Consumer health device expansion creates demand for integrated wearable APIs, cloud health platforms, and compliance-first health data governance.
447 words~2 min read
