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Biolinq’s multi-function biosensor receives FDA De Novo Classification 

September 30, 2025HME News Staff

SAN DIEGO – Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. The device provides additional insights, such as activity and sleep trends, through a mobile app. The company says Biolinq Shine, initially marketed to people with Type 2 diabetes, is the first wearable biosensor integrating...

Biolinq, Biolinq Shine, biosensor, Continuous Glucose Monitor (CGM), wearable

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