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Medical Devices / Submissions and Approvals

FDA Gives Go-Ahead for First Pain Reducing IBS Device for Adolescents

June 11, 2019
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The FDA granted marketing authorization for Innovative Health Solutions’ IB-Stim, the first medical device that helps to lessen functional abdominal pain in younger patients with irritable bowel syndrome (IBS).

The device is intended for patients aged 11 to 18 and is designed for use with other therapies for treating IBS, a condition that can cause abdominal pain and discomfort during bowel movements due to its impact on the large intestines.

The prescription-only device is placed behind the ear to treat IBS pain using mild nerve stimulation in the form of low-frequency electrical pulses.

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