FDA Approves Signos' First Glucose Monitoring System for Weight Management

The Food and Drug Administration has approved the first continuous glucose monitoring system specifically designed for weight management, developed by startup Signos, creating a new accessible option for Americans seeking to manage their weight. Unlike existing treatments such as GLP-1 medications or bariatric surgery that are typically restricted to patients with obesity or specific BMI thresholds, the Signos system is available to any patient regardless of their weight loss goals.

The system combines an artificial intelligence platform with off-the-shelf continuous glucose monitors from Dexcom to deliver personalized, real-time data and lifestyle recommendations for healthy weight management. Patients wear small sensors on their upper arm that track glucose levels and wirelessly transmit data to the Signos app, where they can also log food intake, exercise levels, and other health metrics. The AI platform analyzes this comprehensive data to provide individualized recommendations that help users understand how their bodies respond to specific foods and exercise patterns.

"There is now a solution that everybody can use to help on the weight loss journey, and you don't have to be a certain number of pounds to use it. It's available for the average American who needs it," said Sharam Fouladgar-Mercer, Signos' co-founder and CEO. "The average person might have five pounds to lose, or others might have 100 pounds to lose. We are here to help them at any point in that journey."

The pricing structure makes the system significantly more accessible than alternative treatments. Customers can choose between three-month and six-month plans, priced at $139 and $129 per month respectively, with all necessary CGMs included. This represents a fraction of the approximately $1,000 monthly cost of GLP-1 medications like Wegovy and Zepbound in the United States. While insurance coverage is not currently available for the system when used for weight management, Signos is actively working with health insurance companies and employers to secure coverage options.

The system's versatility extends to its compatibility with other weight management approaches. Patients can use it in combination with GLP-1 medications or following bariatric surgery, and it can also serve as a maintenance tool for those who have discontinued GLP-1 therapy. The company has already served tens of thousands of users over time and has scaled up its CGM inventory and software capacity to handle increased demand following FDA approval. With nearly 74% of Americans classified as overweight or obese and the obesity epidemic costing the U.S. healthcare system over $170 billion annually, Signos aims to make a significant impact on these statistics through its accessible, technology-driven approach to weight management.

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