Biolinq Shine™ Granted De Novo Classification by U.S. FDA

SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach. Initially marketed to people with type 2 diabetes who are not dependent on insulin, Biolinq Shine is the first wearable biosensor integrating glucose, activity, and sleep information in a single device with autonomous operation. A patch on the forearm provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. Additional insights, such as activity and sleep trends, are available through a mobile app. Unlike filament-based glucose sensors, Biolinq Shine eliminates the need for a subcutaneous introducer

Biolinq Shine™ Granted De Novo Classification by U.S. FDA --> Accessibility: Skip TopNav Biolinq Shine™ Granted De Novo Classification by U.S. FDA for the First Fully Autonomous, Needle-Free Glucose Sensor September 25, 2025 08:00 ET | Source: Biolinq Incorporated Biolinq Incorporated First glucose sensor with an integrated primary display that works with and without a phone Establishes a new category of wearable glucose sensors for metabolic health SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Biolinq Incorporated , a pioneering developer of precision multi-analyte biosensors to improve metab

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