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FDA Approves The First Device To Treat Pain Caused By Irritable Bowel Syndrome

 
• By Reed Miller

Innovative Health Solutions IB-Stim percutaneous electrical nerve field stimulator is indicated to aid the reduction of functional abdominal pain in patients ages 11 to 18 with irritable bowel syndrome when combined with other therapies.

Sick woman having a stomach ache, abdomen in black and white, Period cramps concept - Image

The US Food and Drug Administration granted Innovative Health Solutions’ de novo request for its IB-Stim percutaneous electrical nerve field stimulator on 7 June, making it the first device cleared by the agency to treat pain associated with irritable bowel syndrome.

IB-Stim is worn behind the ear, where a small battery-powered chip emits low-frequency electrical pulses to stimulate cranial and occipital nerves. The approved labeling states that IB-Stim helps reduce the...

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