FDA approves first-ever glucose monitoring system for weight loss from Signos

Woman with Signos wearable and appSource: SignosThe Food and Drug Administration on Wednesday approved the first-ever glucose monitoring system specifically for weight loss from the startup Signos, establishing a new option for Americans to manage their weight. Current treatment options for losing weight – popular drugs like GLP-1s and surgical interventions – are typically limited to patients with obesity or a certain BMI. Obesity drugs such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound can also be difficult to access due to their high costs, limited U.S. insurance coverage and constrained supply.But now, any patient can purchase a Signos membership to access its system. It uses an AI platform and an off-the-shelf continuous glucose monitor, or CGM, from Dexcom to offer personalized, real-time data and lifestyle recommendations for weight management. "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, in an interview on Tuesday ahead of the approval. "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 obesity epidemic costs the U.S. health-care system more than $170 billion a year, according to Centers for Disease Control and Prevention data. Almost 74% of Americans are overweight or obese, government data says. Signos hopes it can make a "real big dent in that curve for the betterment of many of us," Fouladgar-Mercer said. Customers who sign up for Signos can choose a three-month or six-month plan, which currently costs $139 and $129, respectively. The company will ship out all of the CGMs a patient needs for the number of months in the plan they choose. Insurers currently don't cover the system for weight management, but the plans are a fraction of the roughly $1,000 monthly price of GLP-1s in the U.S. Signos is working with health insurance companies and employers to get coverage for the system, the company said in a statement to CNBC. Signos said it expects "this to evolve quickly as interest for tackling weight continued to expand." The Signos system can be used in combination with GLP-1s or bariatric surgery, said Fouladgar-Mercer. He said patients can also use the system after getting off a GLP-1 to maintain their weight loss. CGMs are small sensors worn on the upper arm that track glucose levels, mainly for people with diabetes. That data is wirelessly sent to Signos' app, which also allows patients to log their food intake and exercise levels, among other information that the AI platform uses to make recommendations. Apart from helping people lose pounds, the system aims to help users understand how their bodies respond to specific foods and exercise patterns and make the right behavioral changes to manage and maintain their weight in the long term. Signos did not share how many patients are currently using its glucose monitoring system, but Fouladgar-Mercer said tens of thousands of people have already tried it over time. He said Signos has scaled up its CGM inventory and software capacity to "handle a pretty massive scale" following the approval.