Brainsway Ltd., a Jerusalem, Israel-based provider of transcranial magnetic stimulation (TMS) systems for the treatment of neurological and psychopathological disorders, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a system that treats depression. The Deep TMS device is designed for depressed patients who do not respond to therapy.

TMS involves non-invasive but specific stimulation of brain tissue using brief magnetic pulses.

Company officials note that FDA’s cleared indications for the Deep TMS device are particularly broad, which could be indicative of the device’s efficacy in treating depression and a milestone for changing treatments for the disorder. U.S. regulatory approval opens up a potential billion-dollar market to Brainsway.

According to a company statement, Brainsway executives are considering how to market and distribute the Deep TMS device in the United States and other countries, including collaborations with companies that have experience in the business.

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