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FDA Turns to Emerging Tech for Opioid Crisis

It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway. “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,” said FDA Commissioner Scott Gottlieb, MD. Gottlieb said FDA supports the development of both drug and device-based treatments that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids. The NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms, the agency noted. The device is placed behind the ear with microneedle arrays that percutaneously implant in and around the ear. Patients can use the device for up to five days during the acute physical withdrawal phase. Opioid withdrawal causes acute physical withdrawal symptoms including sweating, gastrointestinal upset, agitation, insomnia, and...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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