FDA clears Dexcom's Stelo CGM for OTC use, first without prescription for non-insulin users aged 18+.

The FDA has cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter (OTC) use, marking it as the first continuous glucose monitor (CGM) available without a prescription. Stelo is designed for individuals aged 18 years and older who do not use insulin, including those with diabetes treated with oral medications or those without diabetes seeking to better understand how diet and exercise affect blood sugar levels. The device is not intended for diabetics who use insulin or for individuals with problematic hypoglycemia.

March 05, 2024
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