FDA approves Neurolief's head-worn nerve stimulator as an add-on depression treatment
Proliv Rx stimulates the occipital and trigeminal nerves at home for adults whose depression hasn't responded well enough to antidepressants.
The FDA has granted premarket approval (PMA) to Neurolief’s Proliv Rx, a head-worn device used at home that stimulates the occipital and trigeminal nerves. It is approved as an add-on treatment for major depressive disorder in adults who haven’t responded adequately to antidepressants. Approval was based on the randomized, controlled MOOD study.
Coming a month after Flow’s tDCS headset approval (our coverage), it gives US clinicians a second home-based, non-drug neuromodulation option for depression.
Learn more: Neurotechnology · Neurolief