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# FDA Clears Signos OTC Glucose Monitor
- URL: https://www.fdaweb.com/fda-clears-signos-otc-glucose-monitor/
- Published: 2025-08-22T12:00:00.000Z
- Updated: 2026-09-14T15:19:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159744

FDA has cleared a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically for weight management. The device pairs Dexcom’s Stelo glucose biosensor with Signos’ artificial intelligence-driven platform to provide consumers real-time insights into how diet, exercise, stress and sleep affect their metabolism, according to the company.

Unlike traditional glucose monitors, the product is targeted at people seeking to better manage weight and overall health rather than exclusively those with diabetes, it says. The device is positioned as part of a broader push to make metabolic health tools more accessible without the need for prescriptions. By tracking glucose fluctuations and translating them into personalized recommendations, Signos says it aims to guide users toward sustainable lifestyle changes.