BWAY News & Events

BrainsWay announced that Highmark Blue Cross Blue Shield has released a draft medical policy which, among other developments, expands coverage to include adolescent and adult patients with major depressive disorder, MDD, treated with the company's accelerated Deep TMS protocol. The policy, which is anticipated to go into effect in February 2026 after an open comment period, will provide coverage of BrainsWay's accelerated SWIFT protocol, which consists of an acute phase of five treatment sessions per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions.

BrainsWay 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.