Tag: Biolinq Shine
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...