BrainsWay Receives FDA Clearance for Adolescent Depression Treatment-February 2024-www.financetom.com

BrainsWay Receives FDA Clearance for Adolescent Depression Treatment

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BrainsWay Receives FDA Clearance for Adolescent Depression Treatment

Nov 13, 2025 4:38 AM

07:01 AM EST, 11/13/2025 (MT Newswires) -- BrainsWay ( BWAY ) said Thursday it received US Food and Drug Administration clearance to offer its deep transcranial magnetic stimulation as an add-on treatment for major depressive disorder in patients aged 15 to 21.

The therapy uses magnetic pulses to stimulate brain areas tied to mood and is intended to be used alongside existing care, the company said.

The FDA decision was backed by real-world data from 1,120 adolescents that showed about two-thirds met response after 36 sessions and average symptoms fell by roughly 12 points on a standard depression scale, BrainsWay ( BWAY ) said.

Safety outcomes were consistent with adult use, and clinicians can now use the same system for adults who failed antidepressants and for adolescents as an adjunct, the company added.

Shares of the company were up over 2.2% in recent Thursday premarket activity.

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