Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors for metabolic health, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo Classification for its lead product, Biolinq Shine.

This regulatory milestone establishes a new category of wearable glucose sensors, creating a clear path for Biolinq to scale the next generation of biosensors designed for comfort, simplicity, and global accessibility.

Biolinq Shine is the first fully autonomous, needle-free glucose sensor with an integrated primary display that functions both with and without a smartphone. Initially intended for people with type 2 diabetes who are not dependent on insulin, the device combines glucose monitoring with activity and sleep tracking in a single wearable.

A discreet patch worn on the forearm provides real-time glucose feedback through a color-coded LED display, while deeper insights—such as activity and sleep trends—are available through a companion mobile app.

“The entire Biolinq team is thrilled about this regulatory milestone, which reflects the exceptional dedication and innovation of our people,” said Rich Yang, CEO of Biolinq. “We are grateful to the FDA for its rapid and rigorous review in recognizing this new category of wearable biosensors. While we celebrate this achievement, we believe we are only beginning to unlock the full potential of our multi-analyte biosensor platform to support metabolic health for everyone.”

Dan Bradbury, Chairman of Biolinq, added: “Biolinq Shine is a first-of-its-kind device designed to empower people with diabetes who are not dependent on insulin. By automatically tracking glucose, activity, and sleep, Shine delivers actionable insights that can inspire healthier daily choices.”

The American Diabetes Association (ADA) emphasizes the importance of maintaining glucose levels within the recommended time-in-range (TIR) at least 70 per cent of the time to optimize metabolic health. Traditional glucose monitoring methods often fall short of supporting this goal. With its continuous and autonomous monitoring, Biolinq Shine represents an important step forward in helping individuals achieve better outcomes.

“As long-standing supporters and investors, we remain confident in Biolinq’s ability to deliver on its bold vision for biowearables,” said Rick Gerson, Chairman of Alpha Wave Global. “Biolinq is redefining how society approaches cardiometabolic health and wellness, driving the next wave of innovation with its groundbreaking multi-analyte biosensor platform.”