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Neurostimulator Is First Device Marketed To Reduce Opioid Withdrawal Symptoms

 
• By Sue Darcey

FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.

FDA on Nov. 15 granted Innovative Health Solutions, Inc., a de novo class II designation for the NSS-2 Bridge. The device is a percutaneous nerve field stimulator indicated for use to reduce opioid withdrawal symptoms, the first device to gain such an indication.

"Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently...

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