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FDA Clears Signos’ Over-the-Counter Glucose Monitoring System for Weight Management

The subscription pairs Dexcom’s Stelo sensor with an AI app that personalizes real-time guidance for weight control.

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Overview

  • Regulators approved the first glucose monitoring system in the U.S. explicitly cleared for weight loss.
  • The OTC rollout integrates Dexcom’s Stelo CGM with Signos’ AI to translate glucose readings into individualized lifestyle recommendations.
  • Consumers can enroll without a prescription or BMI requirement through a Signos membership.
  • Plans cost $139 for three months or $129 for six months with sensors included, and insurers do not yet cover the service.
  • Signos says the platform can complement GLP-1 drugs or bariatric care and that inventory and software capacity have been scaled following clearance.