SAN DIEGO — Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today 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 De Novo classification in 2025.
“This clearance represents an important evolution in how people can access glucose information to build greater awareness of their metabolic health,” said Amy VandenBerg, Chief Regulatory and Clinical Officer at Biolinq. “The FDA conducted a thorough and rapid review of our submission, and we appreciate the Agency’s rigor and engagement throughout the process.”
Biolinq Shine is the first glucose sensor with an integrated primary display that works with and without a phone. Worn on the forearm, the patch uses a color-coded LED to communicate real-time changes in glucose levels, signaling when glucose is within, above or below the target range.