The Food and Drug Administration (FDA) has cleared BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) system for the reduction of comorbid anxiety symptoms in adult patients with depression, expanding the indication beyond treatment of depressive episodes.

The outpatient procedure provides noninvasive magnetic stimulation through a cushioned helmet to targeted areas of the brain. The approval was based on data from 573 patients who underwent Deep TMS therapy across 11 studies. According to the Company, the treatment was associated with clinically meaningful reductions in anxiety symptoms in patients with major depressive disorder. The device was compared with both a sham device and standard of care medications.

Data from 3 of the randomized controlled studies showed effect sizes ranging from 0.34 (vs sham) to 0.90 (vs medications), using the Cohen’s statistical method. The overall weighted, pooled effect size was reported to be 0.55, compared with effect sizes ranging from 0.2 to 0.37 across over 70 published studies evaluating drug-based anxiety treatments.

“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “We look forward to continuing to work with our providers to bring the very best in care to the patients that have come to rely on BrainsWay’s deeper and broader neurostimulation and our groundbreaking approach to mental health disorder treatment.”


FDA clears BrainsWay Deep TMS™ System for decreasing anxiety symptoms in depressed patients. News release. August 18, 2021.