Lexology March 28, 2024
McDermott Will & Emery

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM (iCGM) designed for individuals 18 years and older who do not use insulin. Previously, CGMs were only available by prescription and were primarily designed for diabetes management. However, CGMs may offer a new avenue for wellness, proactive health monitoring and accessibility to chronic care management – all without a prescription.

In Depth

UNDERLYING TECHNOLOGY

A Brief History of CGMs

A CGM is a wearable technology that enables users to track their blood sugar levels in real time. Historically, individuals with Type 1 or Type 2 diabetes could...

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Topics: Digital Health, FDA, Govt Agencies, Medical Devices, Technology, Wearables
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