FDA clears first over-the-counter continuous glucose monitor

U.S. Food and Drug Administration sent this bulletin at 03/05/2024 04:57 PM EST

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U.S. Food and Drug Administration, Center for Devices and Radiological Health

FDA Clears First Over-the-Counter Continuous Glucose Monitor

Today, the U.S. Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC) continuous glucose monitor.

The Dexcom Stelo Glucose Biosensor System allows people, 18 years and older, to continuously measure, record, analyze and display glucose values. It is intended for people who do not use insulin, such as individuals 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.

Data from a clinical study provided to the FDA showed that the device performed similarly to other integrated continuous glucose monitors.

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As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, CDRH will continue to support innovation that addresses health equity by moving care and wellness into the home setting.

Questions?

If you have questions about this announcement, contact the Division of Industry and Consumer Education

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