FDA Grants De Novo Clearance to Biolinq’s Needle-Free CGM for Type 2 Diabetes

Biolinq has received FDA de novo classification for its continuous glucose monitor (CGM), Biolinq Shine, designed for people with Type 2 diabetes who do not use insulin. Unlike conventional CGMs, which require a needle to insert a sensor filament beneath the skin, Biolinq Shine uses a microsensor array that sits more superficially, offering a comfortable, needle-free experience. Worn as a patch on the forearm, it measures interstitial fluid and displays glucose readings via a color LED—blue for within-range levels and yellow for high readings—while also tracking sleep and activity metrics through a companion app. Co-founded by CEO Rich Yang and CTO Jared Tangney, Biolinq aims to simplify glucose monitoring and plans to expand to multiple analytes, including ketones and lactate. Earlier this year, the startup secured $100 million in funding to support regulatory approval and commercial launch, positioning Shine as a novel, user-friendly alternative in a competitive CGM market dominated by Abbott and Dexcom.

26-09-2025