CGM System for Weight Loss Receives FDA Clearance

The FDA has cleared the Signos Glucose Monitoring System—the first-ever OTC continuous glucose monitoring (CGM) system for weight management. The product is indicated to guide users’ weight loss with personal data by pairing with Signos’ smartphone app to track food choices, activity, stress, and sleep.¹

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"This is more than a product launch—it's a mission," Sharam Fouladgar-Mercer, CEO and founder of Signos, said in the news release. "Everyone deserves access to insights that help them live healthier, longer, more vibrant lives. Signos isn't just about data; it's about giving people ownership over their health and weight journeys in a way never before seen."¹

Signos's Role in Weight Management

The global diabetes diagnoses are estimated to reach 1.3 billion by 2050, with about 73.6% of US adults currently overweight or obese and 88% classified as metabolically unhealthy. As a wearable device that tracks glucose levels in the interstitial fluid at frequent and regular intervals, CGMs could aid metabolic health among individuals with overweight or obesity.

CGMs have been validated for their accuracy and tolerability in both children and adults in clinical settings and were initially used to manage type 1 diabetes and type 2 diabetes; however, research has expanded to assess their use for weight management.^1,2

According to the company, research has shown that approximately 87% of CGM users change their food choices based on glucose feedback, and nearly half are more likely to exercise when they see a glucose spike. They also noted that more than 90% of users reported that CGMs help them live a healthier lifestyle, allowing them to choose more stable foods or remain active after seeing a rise or fall in their glucose levels.³

Singos CGM Indications

The Signos CGM integrates the Stelo by Dexcom glucose biosensor with an artificial intelligence (AI) platform to help individuals understand how various lifestyle factors impact their bodies in real-time, providing them with the necessary information to make informed decisions based on their unique biology. Specifically, the device aims to start metabolic movement to manage weight and lower individuals’ risk of chronic diseases through a better understanding of their bodies rather than through restriction. Additionally, the AI-driven platform translates glucose fluctuations into easy-to-follow, personalized recommendations that help build healthier habits.¹

The product can be bought through a quarterly subscription plan that includes 6 CGMs for $139 per month. However, the company noted that coverage through a health savings account or flexible spending account could vary, alerting patients to check with their health care provider on eligibility.^3,4

"I've been using Signos for years now, and no matter my mental ups and downs, it is there to keep me in reality. The reality is things change, levels change, but if you keep an eye on the overall picture, you can keep your health in the green. Signos gives me the confidence to enjoy life while being mindful of my body and what it needs,” Raven-Symoné, actress and Signos advisor, said in the news release.¹

REFERENCES

1. Signos Unveils First-Ever FDA-Cleared Glucose Monitoring Breakthrough for Weight Management, Enabling Millions of Americans to Take Control of Their Health. Signos. News release. August 20, 2025. Accessed August 20, 2025. 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

2. Hegedus E, Salvy SJ, Wee CP, Naguib M, Raymond JK, Fox DS, Vidmar AP. Use of continuous glucose monitoring in obesity research: A scoping review. Obes Res Clin Pract. 2021 Sep-Oct;15(5):431-438. doi: 10.1016/j.orcp.2021.08.006. Epub 2021 Sep 2. PMID: 34481746; PMCID: PMC8502209.

3. Signos Inc. Your decisions impact your body. See them. 2025. https://www.signos.com/

4. FDA clears Signos’ over-the-counter, CGM-powered weight loss app. Fierce Biotech. August 20, 2025. Accessed August 20, 2025. https://www.fiercebiotech.com/medtech/fda-clears-signos-over-counter-cgm-powered-weight-loss-app