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FDA Clears Signos’ AI CGM for Weight Management as OTC Service Launches

Powered by Dexcom’s Stelo sensor, the app turns glucose readings into personalized weight guidance.

Overview

  • Regulators granted the first clearance for an app-plus-CGM system specifically for weight management, establishing a new non-drug option in the category.
  • Signos integrates Dexcom’s Stelo sensor with an AI app that analyzes real-time glucose to deliver individualized recommendations and weight targets.
  • Consumers can buy subscriptions without a prescription, with three- or six-month plans priced about $139 and $129 per month and sensors shipped for the full term.
  • Health insurers are not covering the service at launch, and Signos says it is in discussions with plans and employers to pursue reimbursement.
  • The company says the system can complement GLP-1 medications or bariatric surgery and helps users understand responses to food, activity, sleep and stress.