US FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
United States, June 23 -- The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. Prediabetes is increasingly impacting children in the United States, placing millions at heightened risk for progressing to Type 2 diabetes. OTC CGMs can play a critical role in addressing this public health concern for pediatric users who do not use insulin. By providing real-time glucose data, these devices can help...
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