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

Reuters
Updated ·1 min read
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The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

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

Dexcom's shares rose 2.2% in extended trading.

The 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.

Dexcom's Stelo 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.

The device uses a wearable sensor, paired with an application on the user's smartphone or other smart device to continuously measure blood glucose levels.

Stelo will be available for purchase online without a prescription at a competitive price starting in summer 2024, the company said, adding that it plans to share additional pricing details then.

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