Tag: Biolinq
Biolinq glucose sensor receives clearance for OTC use
October 5, 2026HME News Staff
SAN DIEGO – Biolinq Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) use of Biolinq Shine, the company’s needle-free glucose sensor designed to provide a simple, intuitive view of glucose, activity and sleep information in a single device with autonomous operation. The clearance expands access to Biolinq Shine without a prescription, marking the company’s latest regulatory milestone following FDA...
Biolinq’s multi-function biosensor receives FDA De Novo Classification
September 30, 2025HME News Staff
SAN DIEGO – Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. The device provides additional insights, such as activity and sleep trends, through a mobile app. The company says Biolinq Shine, initially marketed to people with Type 2 diabetes, is the first wearable biosensor integrating...
Biosensor tech company secures $100M investment
April 22, 2025HME News Staff
SAN DIEGO – Biolinq, a healthcare technology company of biosensors, has received a $100 million Series C financing led by Alpha Wave Ventures, with participation from existing investors RiverVest Venture Partners, AXA IM Alts, LifeSci Venture Partners, M Ventures, Hikma Ventures, Aphelion Capital, Taisho Pharmaceutical and Features Capital. The funding will support Biolinq through the US regulatory approval process as the company prepares to bring the first autonomous intradermal glucose sensor...