Press release
Stelo by Dexcom First Glucose Biosensor to be 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
About this update from Dexcom, Inc.
[{"type":"text","content":"\n\nStelo will be the first glucose biosensor in the US cleared for use without a prescription\n\n\n\nIndicated for use for people 18 years and older who are not using insulin therapy\n\n\n\nA small, wearable sensor worn on the back of the upper arm, Stelo will provide glucose insights directly to a user’s smartphone†\n\n\n\nCreated by the makers of Dexcom G7, the most accurate,1 easy-to-use2 and clinically-proven CGM brand,3-7 Stelo will empower even more people with Type 2 diabetes not using insulin to take control of health\n\n\n\nStelo will be available summer of 2024\n\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nDexCom, 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.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240305044213/en/Stelo will be the first glucose biosensor in the US cleared for use without a prescription (Photo: Business Wire)\n“Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances. Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks‡ for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”\n\n\nContinuous glucose monitoring plays an integral role in the management of Type 2 diabetes and the benefits are proven when used alone, or alongside other diabetes and weight management medications.8 Studies show th...