FDA Clears Single-use Nerve Stimulation Pain Relief for Adolescents with IBS

IB Stim.png

With the US in the midst of the opioid epidemic, healthcare stakeholders are leveraging technology to create alternative sources of pain relief. Recently, the FDA granted De Novo clearance for a prescription nerve stimulation device called IB-Stim. Developed by Innovative Health Solutions, the device is a single-use electrical nerve stimulator that reduces functional abdominal pain for adolescents and teens with irritable bowel syndrome. It is placed behind the patient’s ear and emits a low-frequency pulse that stimulates cranial nerves to provide pain relief. This isn’t the first time the FDA has provided marketing authorization for a digital health tool to target the opioid crisis and pain management. In recent years, the FDA cleared the NSS-2 BRIDGE, a device used to reduce symptoms of opioid withdrawal and the Electro Auricular Device for use in acupuncture. Neurological medical devices offer the possibility of safer alternatives to pain management.