The Dexcom Stelo Glucose Biosensor System is for adults with or without diabetes who don't use insulin.
The US Food and Drug Administration has cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitoring system.
The Stelo system comprises a wearable sensor paired with an application installed on a smartphone or other reader device. It continuously measures, records, analyzes, and displays glucose values every 15 minutes. Each sensor can be worn for up to 15 days before it must be replaced. It is not intended to be used to make medical decisions without first checking with a healthcare provider.
"CGMs can be a powerful tool to help monitor blood glucose. Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider," said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health.
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