DXCM

US FDA clears use of first over-the-counter continuous glucose monitor

Credit: REUTERS/ANDREW KELLY

Adds device details and background in paragraphs 2-4

March 5 (Reuters) - The U.S. Food and Drug Administration (FDA) has cleared the use of Dexcom's DXCM.O device, making it the first continuous glucose monitor to be available over the counter, the health regulator said on Tuesday.

Dexcom's device, known as Stelo, is intended for use in patients 18 years and older who do not use insulin, such as those with diabetes treating their condition with oral medications or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.

The device is not for individuals with problematic hypoglycemia or low blood sugar as it is not designed to alert the user about this potentially dangerous condition, the FDA said.

Dexcom said Stelo will be available in the summer of 2024.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta and Alan Barona)

((Sriparna.Roy@thomsonreuters.com))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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