FDA Clears BrainsWay Deep TMS Device For Treating Anxiety In Depression

On August 18, 2021, BrainsWay Ltd. announced that its neurostimulation device received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use as a treatment to reduce comorbid anxiety symptoms in adults with depression. With this clearance, BrainsWay is permitted to market its Deep Transcranial Magnetic Stimulation (Deep TMS™) System for this new indication. Comorbid anxiety symptoms are common in people with major depressive disorder. Between 60% to 90% of people with depression have moderate anxiety, and 20% to 25% have more severe anxiety.

The FDA’s clearance was based on data from 573 people who . . .