BrainsWay Receives FDA Clearance for Accelerated Deep TMS Protocol

BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted an expansion of the cleared treatment protocols for its Deep Transcranial Magnetic Stimulation (Deep TMS) system to include an accelerated protocol for treating major depressive disorder (MDD). The accelerated protocol, which involves fewer clinic visits, has shown comparable efficacy to the standard protocol in clinical trials. The new protocol includes an acute phase of 5 sessions per day for 6 days, followed by 2 sessions per day once a week for 4 weeks. The company plans to provide training to healthcare providers and seek updates to reimbursement policies to support the adoption of the new protocol.