August 20, 2021
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BrainsWay receives FDA clearance for noninvasive comorbid anxiety, depression treatment

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The FDA has granted 510(k) clearance to BrainsWay for its noninvasive Deep Transcranial Magnetic Stimulation System to treat comorbid anxiety symptoms in adults with depression, according to a press release.

This clearance allows BrainsWay to market the system to patients with major depressive disorder and anxiety symptoms who experienced subpar improvement from antidepressant medication.

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“Many patients suffering from major depression experience anxiety symptoms,” BrainsWay President and CEO Christopher von Jako, PhD, said in the release. “This most recent regulatory achievement further establishes BrainsWay’s leadership position at the forefront of bringing transformative solutions to advance patient wellness.”

According to the release, data from 11 studies on 573 patients were presented to the FDA, showing that deep transcranial magnetic stimulation (TMS) treatment had “favorable outcomes” in comparison to medication or sham treatment.

“This clearance is confirmation of what many have believed anecdotally for years — that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” Aron Tendler, MD, BrainsWay Chief Medical Officer, said in the release. “We look forward to continuing to work with our providers to bring the very best in care to the patients that have come to rely on BrainsWay’s deeper and broader neurostimulation and our groundbreaking approach to mental health disorder treatment.”