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

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 glucose, activity and sleep information in a single device with autonomous operation. “Biolinq Shine is a first-of-its kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” said Dan Bradbury, chairman of Biolinq. “By automatically tracking glucose levels, physical activity and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.” Biolinq points to American Diabetes Association guidelines that highlight the importance of time-in-range (TIR) for glucose levels in optimizing metabolic health, recommending that individuals diabetes strive to remain within a standard target glucose range at last 70% of the time. It says achieving this target range can be challenging with infrequent and episodic glucose measurements, and a new generation of continuous glucose sensors like Biolinq Shine can be a valuable tool in managing metabolic health. “As long-standing supporters and investors of Biolinq, Alpha Wave remains confident in their ability to deliver on a bold, innovative vision for biowearables,” said Rick Gerson, chairman of Alpha Wave Global. “Biolinq is on the path to redefine how society thinks about cardiometabolic health and wellness, driving the next wave of innovation with a profound multi-analyte biosensor platform.”