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Brainsway Says US FDA Approves Accelerated Protocol for Major Depression Treatment System
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Brainsway Says US FDA Approves Accelerated Protocol for Major Depression Treatment System
Sep 16, 2025 6:24 AM

09:04 AM EDT, 09/16/2025 (MT Newswires) -- BrainsWay ( BWAY ) said Tuesday that the US Food and Drug Administration cleared an accelerated protocol for the company's deep transcranial magnetic stimulation system for the treatment of patients with major depressive disorder, including individuals with comorbid anxiety symptoms.

The expanded clearance was based on data from a study that showed using the accelerated protocol to treat patients with the disorder resulted in outcomes comparable to the standard protocol but with fewer visits to the clinic, with no severe adverse events, the company said.

The company said it will be training healthcare providers to use the accelerated protocol and to update reimbursement models to help with patient adoption.

Shares of the company were up 4.7% in recent premarket activity.

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