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FDA clears first over-the-counter CGM from Dexcom

Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.

This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last year. The San Diego-based company designed it specifically for people with type 2 diabetes who do not use insulin.

Dexcom estimates approximately 25 million people in the U.S. with type 2 diabetes who don’t use insulin but could benefit from CGM use.

The small, wearable sensor is indicated for those 18 years and older who are not using insulin therapy. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone.

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