FDA clears 1st device to enable automated insulin dosing for those with type 2 diabetes

Tuesday, August 27, 2024
WASHINGTON -- The U.S. government has cleared the way for the first medical device that enables automated insulin dosing for people with type 2 diabetes.

The plastic pod, called the Omnipod 5 Automated Insulin Delivery System, is worn on the body.

It delivers insulin based on data sent wirelessly from a glucose monitor, which is also a wearable device.

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Previously, this was only available for people with type 1 diabetes.



The Centers for Disease Control and Prevention said more than 11% of Americans have been diagnosed with diabetes.

"Today's action helps expand access to this important diabetes management tool to millions of adults living in the U.S. with type 2 diabetes," said Dr. Michelle Tarver, acting director of the U.S. Food and Drug Administration's Center for Devices and Radiological Health.
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