Biolinq wins FDA de novo nod for autonomous, needle-free CGM

Biolinq announced today that it received FDA de novo clearance for its lead product, the Biolinq Shine wearable biosensor.

San Diego-based Biolinq can now scale its new generation of wearable sensors designed for comfort, simplicity and global reach. Its Shine sensor integrates glucose, activity and sleep information into a single device with autonomous operation. The company plans to initially market the device to people with type 2 diabetes not dependent on insulin.

The first-of-its-kind system utilizes a patch on the forearm to provide real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. Users can access additional insights for activity and sleep trends through a mobile app.

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