Biolinq announced today that it received FDA de novo clearance for its lead product, the Biolinq Shine wearable biosensor.
San Diego-based Biolinq can now scale its new generation of wearable sensors designed for comfort, simplicity and global reach. Its Shine sensor integrates glucose, activity and sleep information into a single device with autonomous operation. The company plans to initially market the device to people with type 2 diabetes not dependent on insulin.
The first-of-its-kind system utilizes a patch on the forearm to provide real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. Users can access additional insights for activity and sleep trends through a mobile app.
Unlike filament-based continuous glucose monitors (CGMs), Biolinq Shine doesn’t require a subcutaneous introducer needle for placement. It uses a microsensor array manufactured using state-of-the-art semiconductor technology. The company says this registers up to 20 times more shallow than conventional CGM needles.
Shine can help people with diabetes keep their glucose levels in range, the company says, offering a valuable tool in managing metabolic health.
This news comes on the heels of positive data for the company’s biosensors shared at ADA 2025. Biolinq also closed a $100 million Series C funding round to support the technology earlier this year.
“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.”
