Brainsway receives FDA clearance for accelerated Deep TMS for MDD

BrainsWay (BWAY) announced that the U.S. Food and Drug Administration, FDA, has granted an expansion of the cleared treatment protocols for the Company’s Deep Transcranial Magnetic Stimulation system, Deep TMS, to include an accelerated protocol for the treatment of patients with major depressive disorder, MDD, including those with comorbid anxiety symptoms. “We are excited to announce this important FDA clearance of an accelerated treatment protocol for our Deep TMS system, which we are confident will empower providers to treat more patients,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “More than just another clearance, this marks a pivotal advancement in the treatment of depression with Deep TMS because it expands the ways in which we can use Deep TMS to treat depression. While previously, treatment involved 4 weeks of daily treatment sessions before follow up visits, this newly cleared accelerated protocol includes an acute phase of just 6 treatment days.”