Biolinq, a developer of precision multi-analyte biosensors to improve metabolic health, said the FDA has granted De Novo Classification for its lead product, Biolinq Shine. With this classification, Biolinq has a clear path forward to scale the product.
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 semiconductor technology, is up to 20 times more shallow than conventional continuous glucose sensors.
“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.”
