Original from: Biolinq
Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.
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. A patch on the forearm 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 simple user experience delivers a new level of user engagement and confidence in continuous glucose monitoring.
¡°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,¡± said Rich Yang, CEO of Biolinq. ¡°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.¡±
¡°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.¡±
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,¡± 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.¡±
