FDA

FDA clears first glucose monitor for weight management

August 29, 2025

Signos has launched the first FDA-cleared, over-the-counter continuous glucose monitoring (CGM) system designed specifically for weight management. The system integrates Dexcom’s Stelo biosensor with Signos’ AI-powered platform to deliver real-time insights into how food, activity, sleep, and stress affect glucose levels. Unlike traditional CGMs used for diabetes management, this device is intended for adults not on insulin and doesn’t require a prescription.

The Signos platform translates glucose data into personalized recommendations, helping users understand their metabolic responses and make informed lifestyle choices. It aims to support weight loss, improve sleep, and reduce chronic disease risk by empowering users with actionable, biologically driven feedback.

According to a manufacturer press release, this innovation offers a scalable, noninvasive tool for early intervention. For physicians, this may signal a growing interest in CGM technology among patients seeking metabolic health solutions beyond diabetes care. While not a substitute for clinical decision-making, Signos could complement lifestyle counseling and support long-term behavior change in a broader patient population.

Sources:

FDA. 510(k) premarket notification: Signos glucose monitoring system. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250106

(2025, August 20). Signos. Signos Unveils First Ever FDA-Cleared Glucose Monitoring Breakthrough for Weight Management, Enabling Millions of Americans to Take Control of Their Health. [Press release]. https://www.prnewswire.com/news-releases/signos-unveils-first-ever-fda-cleared-glucose-monitoring-breakthrough-for-weight-management-enabling-millions-of-americans-to-take-control-of-their-health-302534147.html