HCP Live March 5, 2024
Patrick Campbell

The FDA has greenlit Dexcom’s Stelo Glucose Biosensor System, marking a historic first as the first continuous glucose monitors to be available over-the-counter.

The US Food and Drug Administration has announced the clearance of Dexcom Stelo Glucose Biosensor System, marking the first time in history the FDA has granted clearance for an over-the-counter continuous glucose monitor.

Announced on March 05, 2024, the decision comes less than 3 months after Dexcom announced it had submitted an application to the US FDA during Q4 2023 for the Stelo sensor on January 08, 2024.1,2

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of...

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Topics: FDA, Govt Agencies, Medical Devices
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