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FDA clears Innovative Health Solutions opioid withdrawal treating neuromod

Innovative Health Solutions won FDA clearance for a new indication for its NSS-2 Bridge device, now cleared to reduce symptoms of opioid withdrawal, according to an FDA release. The NSS-2 Bridge device is a small electrical nerve stimulator designed to be placed behind a patient’s ear and emit electrical pulses to stimulate branches of certain cranial nerves, which may provide relief from opioid withdrawal symptoms. Clearance came based of a single-arm clinical study of 73 patients undergoing opioid physical withdrawal symptoms, with researchers evaluating clinical opiate withdrawal scale scores. Prior to using the device, patients had an average reported COWS score of 20.1. After treatment, all patients showed a COWS score reduction of at least 31% within 30 minutes of using the device. A total 88% of patients transitioned to medication assisted therapy after 5 days of using the device, according to the FDA press release. “Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy. The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid de...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance innovativehealthsolutions Source Type: news

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