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Signos gets FDA green light for over-the-counter CGM for weight management

August 20, 2025 By Sean Whooley

Signos CGM technology
The AI-powered CGM technology in use. [Image courtesy of Signos]
Signos announced today that it launched its FDA-cleared over-the-counter (OTC) glucose monitoring system for weight management.

Palo Alto, California-based Signos integrated the Dexcom Stelo OTC continuous glucose monitor (CGM) with an AI-powered platform for deciphering unique metabolisms. It aims to help people see how food choices, timing, activity, stress and sleep affects their bodies in real time.

The comprehensive metabolic health platform includes proprietary AI with the CGM sensor to provide real-time data and recommendations for weight management. Signos aims for its metabolic-led solution to reverse prediabetes and aid those on their weight loss journey.

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

The Signos system taps into the body’s own signals to equip individuals with the tools to improve sleep, manage weight and reduce the risk of chronic disease. Rather than restrict users, the company says it simply enables understanding.

Working with a smartphone, Signos translates glucose fluctuations into easy-to-follow, personalized recommendations with AI-driven insights. It works to transform raw data into actionable guidance to build healthier everyday habits. Additionally, it helps to create a holistic picture of personal health by enabling users to understand their bodies’ responses.

According to the company, the CGM removes barriers and puts powerful glucose insights into the hands of millions, without the need for prescriptions, high costs or hidden hurdles.

The company launched in 2018. In 2023, it company raised $20 million, with Google Ventures and Dexcom Ventures taking part in the round.

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, Signos

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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