FDA Grants De Novo Classification to Biolinq’s Needle-Free Glucose Sensor

Biolinq Incorporated has been granted U.S. Food and Drug Administration De Novo Classification for its lead product, Biolinq Shine. The classification enables Biolinq to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.

“The entire Biolinq team is thrilled about this regulatory milestone, which is a testament to the outstanding work by our team. We are grateful to the FDA for its rapid and rigorous review in establishing a new category of wearable biosensors,” Biolinq CEO Rich Yang said. “While we celebrate this tremendous milestone, we’ve only scratched the surface of what is possible with our multi-analyte-capable biosensor platform in supporting metabolic health for everyone.”

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, according to the company. A forearm patch 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 company claims. The simple user experience delivers a new level of user engagement and confidence in continuous glucose monitoring.

“Biolinq Shine is a first-of-its kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” Biolinq Chairman Dan Bradbury stated. “By automatically tracking glucose levels, physical activity and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.”

The American Diabetes Association (ADA) guidelines highlight the importance of time-in-range (TIR) for glucose levels in optimizing metabolic health, recommending that individuals with diabetes endeavor to remain within a standard target glucose range at least 70% of the time. Achieving this target range can be challenging with infrequent and episodic glucose measurements. A new generation of continuous glucose sensors such as 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,” Alpha Wave Global Chairman Rick Gerson commented. “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.”

Biolinq Incorporated is a healthcare technology company pioneering precision multi-analyte wearable sensors to improve metabolic health. The company’s biosensor platform is designed to inform and inspire with simplicity to support healthier living. The company is headquartered in San Diego.