FDA OKs Expanded Indication For BrainsWay Deep TMS System - Quick Facts

(RTTNews) - BrainsWay Ltd. (BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced Wednesday that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing the Company to market its Deep Transcranial Magnetic Stimulation (Deep TMS) System for the reduction of comorbid anxiety symptoms in adult patients with depression, also known as anxious depression.

This clearance expands upon BrainsWay's depression indication, and represents yet another in a series of firsts for the Company.

The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.