FDA Clears Deep TMS System for Comorbid Anxiety Symptoms

Today, the Food and Drug Administration (FDA) announced clearance for the Deep Transcranial Magnetic Stimulation (Deep TMS™) System, which was developed by BrainsWay Ltd., for the reduction of comorbid anxiety symptoms in adult patients with depression, otherwise known as anxious depression.

The decision came after the company submitted data from 573 patients who had undergone Deep TMS treatment in 11 studies, including both randomized controlled trials and open-label studies.

Treatment of these patients was considered "consistent, robust, and clinically meaningful" for decreasing anxiety symptoms in adult patients suffering from major depressive disorder in comparison to sham or medication as standard of care.

The labeling by the FDA allows BrainsWay to market the device for the treatment of depressive episodes and for decreasing anxiety symptoms for those who exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder.

The announcement is a promising step in managing comorbid anxiety symptoms, which remains a persistent concern as roughly 60%-90% of patients with depression have moderate anxiety, and 20-25% have more severe anxiety.

In a company statement, Christopher von Jako, PhD, President and Chief Executive Officer of BrainsWay, said Deep TMS “expands upon BrainsWay’s depression indication”, and represents another step forward in managing comorbid anxiety symptoms in patients.

“Many patients suffering from major depression experience anxiety symptoms,” von Jako said. “This most recent regulatory achievement further establishes BrainsWay’s leadership position at the forefront of bringing transformative solutions to advance patient wellness.”