Posted by Michael Wonder on 08 Jun 2019
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
The IB-Stim is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear. It contains a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for five days, at which time it is replaced. Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to three consecutive weeks to reduce functional abdominal pain associated with IBS.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.
