Biolinq Shine™ Receives FDA 510(k) Clearance for Over-the-Counter Use
First needle-free wearable that tracks glucose, activity and sleep in a single device
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SAN DIEGO, Sept. 24, 2026 (GLOBE NEWSWIRE) — 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.
“We believe health technology should make important insights simple, accessible and useful in everyday life,” said Rich Yang, Chief Executive Officer of Biolinq. “This clearance brings that vision closer. By making Biolinq Shine available without a prescription, we can help more people understand how daily choices affect metabolic health and inspire a broader shift toward continuous biosensing as a foundation for healthier living.”
Biolinq Shine uses semiconductor-based microsensors that sit close to the skin’s surface without a needle for placement. The device combines glucose, activity and sleep insights in a simple wearable experience, with an optional companion app that helps people see how meals, rest and movement affect glucose levels.
Biolinq Shine is intended for adults ages 22 and older who are not on insulin and provides glucose range information to support general awareness of glucose patterns and trends. Biolinq Shine is not intended to provide quantitative glucose concentration values for acute medical decision-making, including insulin dosing or medication adjustments.
About Biolinq Incorporated
Biolinq Incorporated is a healthcare technology company pioneering precision multi-analyte wearable sensors to improve metabolic health. The company’s biosensor platform is designed to inform and inspire with unparalleled simplicity to support healthier living. With microsensors that reside just below the skin’s surface, Biolinq is redefining the future of continuous biosensing. The company is headquartered in San Diego, CA. For more information, please visit www.biolinq.com.
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Sofia Bermudez
LifeSci Communications
sbermudez@lifescicomms.com
