Biolinq Incorporated - FDA 510(k) Cleared Devices

Biolinq Incorporated, develops continuous glucose monitoring devices with a manufacturing facility in San Diego, US. The company specializes in innovative Chemistry devices designed to simplify glucose monitoring and metabolic health tracking.

Biolinq Shine is the company's flagship product-a needle-free, autonomous glucose sensor cleared by the FDA in 2025. It integrates glucose monitoring with activity and sleep tracking in a single device, featuring a color-changing indicator light for real-time glucose range feedback. The device is intended for persons 22 years or older not on insulin and provides personalized insights through a companion mobile application.

Biolinq Incorporated has submitted 1 FDA 510(k) application and received 0 clearance to date. The company's regulatory record reflects focus on Chemistry devices for continuous metabolic monitoring. Explore device names, product codes, and clearance dates in the 510(k) database.