FDA Approves First Over-the-Counter Continuous Glucose Monitor

6 Mar 2024 • The U.S. Food and Drug Administration has granted clearance for the first over-the-counter continuous glucose monitor (CGM).

This integrated CGM is designed for individuals aged 18 and older who are not on insulin and do not have problematic hypoglycemia.

The system utilizes a wearable sensor paired with a smartphone app to continuously measure, record, analyze, and display glucose values, offering readings and trends every 15 minutes.

However, users are advised not to make medical decisions solely based on the device's output without consulting their healthcare provider. Adverse events reported in the study include local infection, skin irritation, and pain or discomfort.

Source: FDA | Read full story

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