FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

View source ↗

Summary

FDA cleared the first over-the-counter continuous glucose monitor for children, Dexcom Stelo Glucose Biosensor System, for non-insulin-using individuals aged 2 …

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Diabetes Mellitus

Drugs mentioned

• Stelo Glucose Biosensor System

Snippet

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.