News & Press
Neurolief ProlivRx Receives FDA PMA Approval for At-Home Depression Neuromodulation
PR Newswire1/12/2026·01/12/26🌐 USA
Summary
Neurolief ProlivRx received FDA Premarket Approval for adults with major depressive disorder who did not respond adequately to at least one antidepressant.
Why it matters
FDA PMA approval for at-home depression neuromodulation moves neurostimulation from clinic-only delivery to patient-administered treatment, dramatically expanding the addressable population and reducing cost per treatment course. This is a landmark for accessibility in a field that has historically required specialist referral.
#BCI#Depression#FDA#Neurostimulation
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