On Sept. 25, 2025, Biolinq, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, 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 needle for sensor placement. Its microsensor array, manufactured using state-of-the-art semiconductor technology, is up to 20 times more shallow than conventional continuous glucose sensors. The simple user experience delivers a new level of user engagement and confidence in continuous glucose monitoring.