BrainsWay (BWAY) announced that the U.S. Food and Drug Administration, FDA, has granted Premarket Approval, PMA, for Neurolief’s ProlivRx system, a Class III device, as an adjunctive treatment for adult patients suffering from major depressive disorder, MDD, who have failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in the clinic. This approval represents a significant regulatory milestone, making ProlivRx the first and only at-home neuromodulation treatment with FDA labeling applicable to treatment refractory MDD patients.
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