Neurolief Receives FDA PMA Approval For At-Home Neuromodulation Therapy For Treatment-Resistant Depression

Neurolief Inc., a medical device company focused on neuromodulation therapies for neuropsychiatric conditions, announced that the U.S. Food and Drug Administration (FDA) has approved ProlivRx, the first prescription, physician-directed, at-home brain neuromodulation therapy as an adjunctive treatment for adults with Major Depressive Disorder (MDD) who who did not achieve adequate response 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 ProlivRx for use by people with MDD who had an inadequate response to . . .