Shots:
- The US FDA has granted Breakthrough Device Designation for its NET Device as an aid in reducing psychostimulant use in adults diagnosed with stimulant use disorder, incl. cocaine use disorder & amphetamine-type/ methamphetamine use disorder
- NET Recovery is designing a pivotal randomized controlled trial intended to support FDA marketing authorization, which the company believes will proceed through the De Novo review pathway
- The NET Device is an FDA-cleared transcutaneous alternating current stimulator (tACS) for managing opioid withdrawal symptoms alongside standard medications & other withdrawal therapies
Ref: PRnewswire | Image: NET Recovery | Press Release
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