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# Biolinq Gets De Novo for Glucose Sensor
- URL: https://www.fdaweb.com/biolinq-gets-de-novo-for-glucose-sensor/
- Published: 2025-09-25T12:00:00.000Z
- Updated: 2026-09-14T15:22:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159941

FDA has granted Biolinq a *de novo* authorization for its Shine system, the first fully autonomous, needle-free glucose sensor in the U.S, according to the company. The device features an integrated display and does not require a smartphone to deliver glucose readings.

Unlike traditional continuous glucose monitors that use a subcutaneous filament, Shine includes a microsensor array that sits closer to the skin surface — up to 20 times more shallow than conventional devices, Biolinq says. The patch, worn on the forearm, provides real-time glucose feedback through a color-coded LED display, while additional data on activity and sleep can be accessed via a mobile app.