FDA approves Signos glucose monitoring for weight loss

The FDA clears Signos system that uses AI and a Dexcom CGM to aid weight management for a broad audience.

FDA approves Signos glucose monitoring for weight loss

The FDA on Wednesday approved Signos glucose monitoring as the first system designed specifically for weight loss. The setup uses Signos AI with an off the shelf Dexcom CGM to provide real time glucose readings and personalized lifestyle tips. Customers sign up for three months or six months; the plan costs 139 dollars for the shorter option and 129 dollars for the longer one. Signos will ship all needed CGMs for the duration of the plan.

Insurers do not cover weight management systems yet, but Signos says it is talking with insurers and employers to change that. The system can be used with GLP 1 drugs or after bariatric surgery and can help after someone stops a drug to keep weight off. CGMs send data to a mobile app where users log food and activity and the AI uses that data to tailor recommendations. Tens of thousands have tried it over time and Signos has expanded its CGM inventory and software to prepare for scale ahead of the regulatory approval.

This marks a notable shift toward tech aided weight management that sits between medical devices and consumer wellness. Making the tool accessible without BMI thresholds could broaden reach, but it also raises questions about affordability and who benefits if coverage lags. Regulators are weighing safety and privacy as data flows through an always connected app. The move could pressure insurers and providers to rethink how weight care is funded and delivered, with potential ripple effects for patients, employers and public health policy.

Highlights

Policy makers will watch how coverage evolves as more digital health tools enter weight care.