FDA clears accelerated protocol for BrainsWay Deep TMS in depression

BrainsWay (Nasdaq:BWAY) today announced the FDA granted expanded clearance for its Deep Transcranial Magnetic Stimulation system to include an accelerated treatment protocol for major depressive disorder and patients with comorbid anxiety symptoms.

The accelerated protocol allows for an acute phase of six treatment days, compared to the four weeks of daily sessions required under the standard protocol. Each session lasts less than 10 minutes.

“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,” CEO Hadar Levy said in a news release. “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.”

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