Signos Wins Clearance for First Over-The-Counter CGM for Weight Management

Signos has announced the launch of the first FDA-cleared, over-the-counter continuous glucose monitoring (CGM) system designed for weight management. The Signos Glucose Monitoring System integrates the Dexcom Stelo glucose biosensor with an artificial intelligence (AI)-powered digital platform that provides real-time data on how food, activity, sleep, and stress affect the body.

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Beyond the traditional use of glucose monitoring for management of diabetes, the device provides metabolic insights that can inform long-term health in addition to weight management, the company said in a statement.

“This is more than a product launch — it’s a mission,” Sharam Fouladgar-Mercer, CEO and Founder of Signos, said in the statement. “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

US Metabolic Health in Decline

The Signos device enters the wearable health tracker market as data show that nearly three-quarters (73.6%) of adults in the US are classified as overweight or obese and 88% are metabolically unhealthy.² Metabolic syndrome is diagnosed when an individual has at least 3 of the following: increased waist size, elevated serum triglycerides, low HDL-C, elevated serum glucose, and elevated blood pressure.³ The cluster of conditions is associated with increased risk of heart disease, stroke, and type 2 diabetes and is estimated to affect approximately 42% of adults in the US.³ Metabolic syndrome will contribute to the projected prevalence of diabetes diagnoses by 2050 of 1.3 billion.⁴ With the Signos Glucose Monitoring System, the company seeks to address the risks by helping individuals become aware of their own metabolic health and to make lifestyle changes earlier, according to the statement.¹

Signos translates fluctuations in glucose into individualized recommendations that users can apply to daily habits. The company highlights its focus on “total body intelligence,” which links glucose levels to meals, workouts, sleep, and stress. The system is available without a prescription to help expand access to the tool beyond traditional diabetes care.¹

Actor and advisor Raven-Symoné described her personal experience with the system, stating, “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.”¹

Wearable Health Technology Boom

The introduction of Signos reflects a broader shift in metabolic health technology. Continuous glucose monitors, once limited to diabetes management, are now being adapted for preventive health and general wellness, eg, tracking steps or heart rate to monitor sleep, stress markers, cardiac rhythm, oxygen saturation, and blood pressure. A national survey showed that 36.4% of respondents used a health care wearable device in the past 12 months, with 43.5% of those reporting daily use.⁵ Another study found that about 39% of US adults now wear a smartwatch, underscoring the growing integration of wearable health tools in daily life.⁶

By providing real-time feedback, all of these platforms could help shift the emphasis of US health care from treatment of disease to prevention, allowing individuals to act on physiologic signals before conditions such as type 2 diabetes and heart disease develop, Signos said.

The widespread access of metabolic health monitoring, however, raises questions for clinicians and regulators about data quality, safety, and privacy. While FDA clearance for the Signos system signals a level of oversight, the use of consumer-accessible metabolic sensors outside traditional disease management presents both opportunities and challenges. For clinicians, patients may increasingly arrive with self-tracked metabolic data that can complement or complicate care.

Whether consumer adoption of such tools will lead to measurable improvements in public health remains to be seen, but the FDA clearance of Signos marks a notable milestone in the evolution of wearable health technology, the company said.

References

1. Signos unveils first ever FDA-cleared glucose monitoring breakthrough for weight management, enabling millions of Americans to take control of their health. News release. Signos. August 20, 2025. Accessed August 25, 2025. https://prnmedia.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. Obesity and overweight. National Center for Health Statistics. Updated October 5, 2024. Accessed August 25, 2025. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm

3. Prevalence of metabolic syndrome in the United States National Health and Nutrition Examination Survey 2011-18. Postgrad Med J. 2023;99(1175):985-992. doi: 10.1093/postmj/qgad008.

4. GBD 2021 Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;402(10397):203-234. doi:10.1016/ S0140-6736(23)01301-6