medical device

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

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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.