BrainsWay Gains 510(k) Clearance for Anxiety-Reducing Device

BrainsWay has received expanded 510(k) clearance from the FDA for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, intended to reduce anxiety symptoms in adult patients with major depressive disorder.

The company said it submitted supporting data from 573 patients who had undergone Deep TMS treatment in 11 studies that showed a “robust” clinical benefit.

The new clearance allows BrainsWay to market the system for treatment of adult patients suffering from major depressive disorder who have failed to achieve satisfactory improvement from antidepressant medications.