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See today's BioWorld MedTech
Home » FDA clears Dexcom Stelo as first OTC continuous glucose monitor
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FDA clears Dexcom Stelo as first OTC continuous glucose monitor

March 7, 2024
By Annette Boyle
In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity.
BioWorld MedTech Regulatory Diabetes Endocrine/metabolic U.S. FDA

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