FDA Clears First OTC Continuous Glucose Monitor for Type 2 Diabetes
March 6, 2024The 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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Sources
Investopedia • Mar 6, 2024
Dexcom Gets FDA Clearance for OTC Glucose Monitor, and Stock JumpsMedical Xpress • Mar 6, 2024
FDA clears first OTC continuous blood glucose monitor