Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

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Dexcom’s new over-the-counter continuous glucose monitoring (CGM) solution, Stelo, has been cleared by the FDA. It is a wearable biosensor that provides round-the-clock glucose readings directly to a smartphone. The patch, which adheres to the back of the upper arm, detects normal, low, and high glucose levels and offers personalized insights into glucose health. Targeted at individuals 18 and older who do not require insulin, Stelo is designed for those managing diabetes with oral medications or needing information on the impact of lifestyle factors on blood sugar levels. Dexcom is also rolling out a “direct to Apple Watch” functionality for its CGM system. Other players in digital diabetes management include Kakao Healthcare’s AI-driven mobile app PASTA and Valendo Health, which offers telehealth and remote patient monitoring services.

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