Neurolief receives FDA nod

Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants

January 12, 2026
11:24 am

CORAL SPRINGS, Fla., Jan. 12, 2026 /PRNewswire/ -- Neurolief Inc., a medical device company focused on neuromodulation therapies for neuropsychiatric conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved Proliv™Rx, the first prescription, physician-directed, at-home brain neuromodulation therapy as an adjunctive treatment for adults with Major Depressive Disorder (MDD) who failed to achieve satisfactory improvement from at least one previous antidepressant medication.

The approval under the Class III Premarket Approval (PMA) pathway was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating Proliv™Rx in MDD with inadequate response to antidepressant medications.

“The Proliv™Rx pivotal study results represent an important new option for patients who have not responded adequately to medications,” said Mark S. George, MD, a Principal Investigator of the MOOD clinical trial and Professor of Psychiatry and Neurology at the Medical University of South Carolina (MUSC). “This effective and highly accessible therapy with a favorable safety profile, addresses a significant unmet need in this underserved patient population and expands how we can deliver care.”

This approval gives clinicians and health systems scalable next-step therapy when medications fail, enabling clinically validated brain neuromodulation to be delivered at home under physician oversight, without the access constraints, infrastructure, or operational burden of clinic-based interventions.

Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants

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