The FDA has granted De Novo Classification for Biolinq Shine, a first-of-its-kind, needle-free glucose biosensor with LED glucose status, for adults with type 2 diabetes not on insulin. De Novo Classification is reserved for novel medical devices with no existing equivalent, allowing the FDA to classify innovative products based on their actual risk profile rather than defaulting to the highest-risk category. This milestone creates a new regulatory category for wearable biosensors, opening the door for wider use of simple, needle-free glucose monitoring.

Biolinq Shine was developed by Biolinq Inc., a health tech company based in San Diego that specializes in precision wearable biosensors for metabolic health. The Shine sensor uses a microsensor array that rests just beneath the skin, up to 20x more shallow than traditional continuous glucose monitors (CGMs), removing the need for insertion needles or filaments.

The patch, worn on the forearm, provides color-coded LED feedback directly on the device, allowing users to instantly see their glucose levels without a phone. The system also tracks activity and sleep, offering a more complete view of metabolic health through its companion app.

Looking ahead, Biolinq plans to commercialize Shine and expand its biosensor platform to track additional metabolic markers such as ketones and lactate, supporting broader cardiometabolic health monitoring. The company recently raised $100 million to support launch and scale-up efforts, signaling strong investor confidence in its mission to make continuous health tracking more comfortable, accessible, and integrated for everyday users.

Biolinq Shine is the first needle-free CGM to receive FDA clearance, but it’s not the only one in development — both Sava and Trinity Biotech are working on needle-free CGMs, and Abbott is developing a ketone sensor, signaling a growing push toward multi-analyte monitoring for people with diabetes.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.