FDA Clears First OTC Continuous Glucose Monitor for Type 2 Diabetes

March 6, 2024
FDA Clears First OTC Continuous Glucose Monitor for Type 2 Diabetes
  • The FDA has approved Dexcom's Stelo Glucose Biosensor System, a first over-the-counter continuous glucose monitor for type 2 diabetes.

  • Designed for adults 18+ who are not on insulin, the Dexcom Stelo can be worn on the upper arm and syncs glucose readings to a smartphone.

  • This approval allows individuals to access continuous glucose monitoring without a prescription, potentially expanding its use.

  • Dexcom's stock value increased by over 8% after the announcement, marking the highest share price since July.

  • An estimated 25 million Americans could benefit from the Stelo device, offering a new option for those without insurance.

  • The cost of the new device was not disclosed, but its sensor is designed to last up to 15 days.

  • The FDA's decision is viewed as a move toward improving health equity among U.S. patients.

Summary based on 2 sources


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