FDA Approves Signos’ First-Ever Glucose Monitoring System for Weight Loss

The Food and Drug Administration (FDA) has approved the first-ever glucose monitoring system specifically designed for weight loss, developed by the startup Signos. This approval represents a significant advancement in weight management options for Americans, providing an accessible, technology-driven alternative to traditional obesity treatments. Traditionally, weight-loss interventions have included GLP-1 drugs and surgical procedures, which are generally limited to patients with obesity or a specific Body Mass Index (BMI). Drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound are effective but often inaccessible due to high costs, limited insurance coverage in the United States, and supply constraints. Signos’ system, by contrast, is available to anyone through a membership, democratizing access to weight management tools.

Signos employs a combination of an artificial intelligence (AI) platform and a continuous glucose monitor (CGM) from Dexcom, providing users with personalized, real-time data. This data-driven approach allows for tailored lifestyle recommendations, helping patients make informed decisions regarding diet, exercise, and overall health. According to Sharam Fouladgar-Mercer, Signos’ co-founder and CEO, the system is designed for users of all weight ranges. Whether a person needs to lose a few pounds or over a hundred, Signos aims to support every stage of the weight-loss journey.

The obesity epidemic imposes a tremendous financial burden on the U.S. healthcare system, costing over $170 billion annually, according to the Centers for Disease Control and Prevention (CDC). Nearly 74% of Americans are classified as overweight or obese. Signos aims to make a substantial impact on this crisis, providing accessible solutions that improve health outcomes for a large portion of the population. Customers can select from three-month or six-month membership plans, priced at $139 and $129, respectively. Signos supplies all necessary CGMs for the duration of the plan, allowing seamless tracking and engagement with the AI platform.

While current health insurers do not cover Signos for weight management, the cost of its plans is significantly lower than monthly GLP-1 treatment costs, which can approach $1,000. Signos is actively collaborating with insurers and employers to make the system more widely accessible and anticipates rapid growth in user interest as public awareness of weight management technologies increases.

The Signos system can be used alongside GLP-1 therapies or bariatric surgery. Patients may also continue to use the system after discontinuing GLP-1 treatment to maintain their weight loss. CGMs are small sensors worn on the upper arm that monitor glucose levels, primarily for diabetics. This data is transmitted wirelessly to the Signos app, which also allows users to log their food intake and exercise, among other relevant metrics. The AI platform processes this information to provide actionable recommendations.

Beyond weight loss, the system educates users about their bodies’ responses to different foods and exercise routines, encouraging long-term behavioral adjustments to sustain healthy weight. Tens of thousands of users have already engaged with Signos’ platform, according to Fouladgar-Mercer. The company has expanded its CGM inventory and software infrastructure to support large-scale adoption following FDA approval, demonstrating readiness for broader implementation.

Overall, the FDA approval of Signos’ glucose monitoring system introduces a novel, technology-driven, and inclusive approach to weight management, combining real-time physiological tracking, AI-powered recommendations, and flexible usage for individuals across all stages of weight loss. This innovative system addresses key gaps in accessibility, affordability, and personalized care, positioning Signos as a significant player in combating obesity in the United States.