BrainsWay Receives FDA Clearance for Three-Minute Theta Burst Treatment Protocol for Major Depressive Disorder

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(T)he U.S. Food and Drug Administration (FDA) granted 501(k) clearance for the Company’s Theta Burst three-minute protocol utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) system for the treatment of major depressive disorder (MDD).

“Adding our three-minute treatment protocol to the list of growing solutions available to our provider partners expands the platform nature of this lifechanging technology,” said Hadar Levy, Senior Vice President and General Manager of BrainsWay. “Many patients and providers can benefit from significantly shorter treatment sessions, and our Theta Burst protocol can provide these patients with another option to manage their treatment resistant depression.”

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