Medical Economics March 6, 2024
Grace Halsey

Sensor paired with smartphone app measures glucose values every 15 minutes.

The Dexcom Stelo Glucose Biosensor System won U.S. Food and Drug Administration (FDA) clearance on March 5, 2024, to become the first-ever over-the-counter continuous glucose monitor (CGM), according to a company announcement.

Use of the integrated CGM (iCGM) system, available without a prescription from a health care professional, is intended for use by adults aged 18 years and older who do not use insulin, which could include individuals with Type 2 diabetes who use oral medications, the FDA said, a population estimated at 25 million in the United States. The system is not equipped with an alert feature and so should not be used by anyone with problematic hypoglycemia,...

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Topics: FDA, Govt Agencies, Medical Devices, Patient / Consumer, Provider
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