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.

See full article: https://www.massdevice.com/biolinq-fda-nod-autonomous-needle-free-cgm/