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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...

510(k) clearance, Biolinq, Biolinq Shine, Diabetes, Food & Drug Administration (FDA), glucose sensor, Over the counter

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