FDA Approved | Image credit: chrisdorney – stock.adobe.comThe FDA greenlit marketing for the Dexcom Stelo Glucose Biosensor System on Tuesday, making it the first over-the-counter (OTC) continuous glucose monitor (CGM) available for purchase, according to an FDA news release.1 The device will be available summer 2024. It’s important to note the Dexcom Stelo Glucose Biosensor System is not designed for individuals with problematic hypoglycemia (low blood sugar), as it cannot alert users to this potentially dangerous condition. With each sensor lasting up to 15 days, users can track glucose trends every 15 minutes via the app. Clinical data submitted to the FDA demonstrated the device's performance comparability with other integrated CGM systems. In September 2016, the FDA granted approval for the Freestyle Libre Pro Glucose Monitoring System, a CGM system intended for blinded professional use in clinics, and approved it for personal use by patients the following year.

Source: New York Times March 07, 2024 14:32 UTC