FDA Clears Deep Transcranial Magnetic Stimulation for Adolescents With MDD

BrainsWay announced that the US Food and Drug Administration (FDA) has granted a label expansion for the deep transcranial magnetic stimulation (Deep TMS) system that makes the treatment available as an adjunct therapy for adolescents aged 15 to 21 years who have major depressive disorder (MDD).¹ Before this approval, Deep TMS was only indicated for patients with MDD aged 22 to 86 years.²

“The FDA’s clearance of this expanded label enables access to Deep TMS for the critically important adolescent patient population, which is often underserved by traditional pharmacological options to manage major depressive disorder,” said Colleen Hanlon, PhD, the vice president of medical affairs at BrainsWay.

The FDA provided 510(k) clearance following BrainsWay’s submission of a robust data set, including real-world evidence collected from 1120 adolescents (aged 15-21) treated across 35 TMS centers in the US between the years 2012 and 2024. Data from high-frequency (18 Hz) and intermittent theta-burst Deep TMS protocols were included. The Deep TMS procedure provides patients with noninvasive magnetic stimulation through a cushioned helmet to induce electrical currents in localized regions of the prefrontal cortex. As measured by the self-administered Patient Health Questionnaire-9 rating scale, the results demonstrated that, following 36 treatment sessions, adolescent patients saw an average improvement of 12.1 points and a 66.1% response rate (defined as an improvement from baseline of 50% or greater). Investigators also noted meaningful reductions in anxiety symptoms as measured by the self-administered Generalized Anxiety Disorder scale, consistent with prior adult studies. As to safety profile, outcomes were consistent with previous adult studies.

“The 510(k) clearance was supported by our submission of one of the largest real-world adolescent neuromodulation datasets ever presented to the US FDA, which demonstrated compelling efficacy and safety in reducing depressive symptoms, as well as substantial improvements in comorbid anxiety. This reinforces BrainsWay’s position in the market as the leader of evidence-based, noninvasive treatment for depression across all age groups,” said Hanlon.

The BrainsWay Deep TMS System is now available for the treatment of depressive episodes and comorbid anxiety symptoms in adults with MDD who have failed to achieve satisfactory response from previous antidepressant medication treatment in the current episode, and as an adjunct therapy for adolescent patients aged 15-21.

“We are excited at the opportunities this clearance can bring, for both the young people suffering from this often debilitating condition, and for their parents who have struggled for so long to find treatment solutions that can bring some joy and hope back into their family life,” said Hadar Levy, the chief executive officer of BrainsWay. “This clearance will allow us to reach the broadest age range of any TMS system for the treatment of depression. With approximately 5 million adolescents in the US estimated to have experienced a major depressive episode within the past year, this represents a significant milestone for us to be able to address an important segment of the MDD patient population. Clinicians can now treat both adults and adolescents using the same Deep TMS system and established stimulation protocols.”

References

1. BrainsWay receives FDA clearance of deep TMS™ as adjunct therapy for major depressive disorder (MDD) in adolescents aged 15 to 21. News release. November 13, 2025. Accessed November 14, 2025. https://www.globenewswire.com/news-release/2025/11/13/3187099/17676/en/BrainsWay-Receives-FDA-Clearance-of-Deep-TMS-as-Adjunct-Therapy-for-Major-Depressive-Disorder-MDD-in-Adolescents-Aged-15-to-21.html

2. BrainsWay receives FDA clearance for accelerated deep TMS protocol for non-invasive treatment of major depressive disorder (MDD). News release. September 16, 2025. Accessed November 14, 2025. https://investors.brainsway.com/news-releases/news-release-details/brainsway-receives-fda-clearance-accelerated-deep-tms-protocol