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Stelo by Dexcom First Glucose Biosensor Cleared by FDA as Over-the-Counter

• Stelo will be the first glucose biosensor in the US cleared for use without a prescription

• Indicated for use for people 18 years and older who are not using insulin therapy

• A small, wearable sensor worn on the back of the upper arm, Stelo will provide glucose insights directly to a user’s smartphone

• Created by the makers of Dexcom G7, the most accurate, easy-to-use and clinically-proven CGM brand, Stelo will empower even more people with Type 2 diabetes not using insulin to take control of health

• Stelo will be available summer of 2024

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription. There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology. Today, Dexcom G7 is available for them with a prescription. Stelo, cleared for use without a prescription, will make it even easier for this population to access leading CGM technology, and will provide an option for those who do not have insurance coverage for CGM. Read more >

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