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RegulationJune 15, 2026

FDA clears Dexcom’s Stelo as first OTC glucose monitor for children

The FDA cleared Dexcom's Stelo continuous glucose monitor (CGM) for over-the-counter use in pediatric patients, making it the first OTC CGM approved for children. The clearance expands the product's indication from adults to include pediatric users with diabetes, enabling direct consumer access without prescription.

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