Biolinq Shine Receives FDA Clearance for Over-the-Counter Use
News related to:Biolinq Incorporated · 1 min read
SAN DIEGO, Sept. 24, 2026 /CourierPR/ -- Biolinq Incorporated, a company at the forefront of precision multi-analyte biosensor technology, has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its needle-free glucose sensor, Biolinq Shine™, for over-the-counter (OTC) use. This clearance marks an important step in making glucose monitoring more accessible to a broader audience without the need for a prescription.
The FDA's decision comes after a thorough and rapid review of the company's submission, underscoring the rigorous standards and engagement throughout the process.
Biolinq Shine™ is designed to provide a simple, intuitive view of glucose, activity, and sleep information in a single device, with autonomous operation. The sensor, worn on the forearm, uses a color-coded LED to communicate real-time changes in glucose levels, signaling when glucose is within, above, or below the target range. This innovative approach aims to make health technology more accessible and user-friendly, enabling individuals to understand how daily choices affect their metabolic health.
Biolinq Shine uses semiconductor-based microsensors that sit close to the skin's surface without the need for a needle. The device combines glucose, activity, and sleep insights in a simple wearable experience, with an optional companion app that helps users see how meals, rest, and movement affect glucose levels. The sensor 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. It is not intended to provide quantitative glucose concentration values for acute medical decision-making, including insulin dosing or medication adjustments.
Biolinq Incorporated, headquartered in San Diego, California, continues to pioneer 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.