Signos recently announced the launch of its glucose monitoring system for weight management, describing it as the "first ever FDA-cleared" system of its kind. However, the FDA has not cleared or approved the Signos app for weight loss.
FDA records (510(k) K250106) show that the clearance covers the Signos Glucose Monitoring System as an over-the-counter app that displays glucose data from Dexcom’s Stelo sensor. The FDA notes the app may help users understand how diet and exercise affect glucose and “may be useful in helping users maintain a healthy weight,” but it is not cleared as a treatment or tool for weight loss.
The underlying sensor, Stelo, is cleared for over-the-counter use in adults not on insulin. No continuous glucose monitor has FDA approval for weight loss, and there is no strong scientific evidence that CGM use directly supports weight management.
By blending the FDA clearance of Stelo with claims about its app, Signos’ announcement risks creating the impression that the whole system is FDA-approved for weight loss. That is not the case. For context: CGMs are vital for people with diabetes who use insulin, very helpful for those with type 2 diabetes who do not, and generally unnecessary for people without diabetes.
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