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BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

BrainsWay’s strategic investment in Neurolief paved the way for the first and only FDA approved at-home neuromodulation device with Class III Premarket Approval labeling for MDD patients who failed one or more prior antidepressantsBURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (F

articleBrainsway LtdJanuary 12, 20265/company/brainsway-ltd/news/brainsway-announces-fda-approval-neurolief-123000248
BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

About this update from Brainsway Ltd

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More updates from Brainsway Ltd

Premarket ApprovalFood and Drug AdministrationThe companymajor depressive disorderBrainsWayantidepressant medicationadjunctive treatmentsatisfactory improvementNeuroliefmental healthCompany