Glucose biosensors
Biolinq Shine
Biolinq
Wearable glucose sensor from Biolinq that uses an array of intradermal microsensors and, per Biolinq, needs no hypodermic needle for insertion. A color LED on the sensor shows glucose ranges without a phone (blue = in target range, yellow = above range, per Biolinq); the same device tracks activity and sleep with an accelerometer and ambient light sensor, and an optional app shows more detailed glucose information. Regulatory: FDA Class II Glucose Range Monitoring System (product code SFU, 21 CFR 862.1359); De Novo DEN240080 granted Sep 23, 2025 and 510(k) K262599 cleared Sep 18, 2026 (FDA device name: Biolinq Shine Autonomous Time-in-Range Microsensor). Biolinq's labeling covers people 22 years or older not on insulin. FDA's definition of this device type says the readings are not quantitative glucose values and are not for acute medical decisions such as insulin dosing or medication adjustment; Biolinq says users should not take medical action based on the device output without consulting a qualified healthcare professional. Availability: not yet available for purchase; as of Oct 5, 2026, biolinq.com shows no price, launch date, pre-order or waitlist. Biolinq has not published a price, wear duration or accuracy (MARD) figure.
Listed for: US
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