FDA Approves Deep Transcranial Magnetic Stimulation Device for MDD Treatment in Youth Ages 15 to 21, BrainsWay Announces

The FDA has cleared BrainsWay's Deep TMS (Transcranial Magnetic Stimulation) system for use as adjunct therapy in adolescents aged 15 to 21 years with major depressive disorder (MDD), according to the manufacturer, making it the first TMS device approved to treat depression across individuals aged 15 to 86. The November 13 clearance expands access to the noninvasive therapy, which delivers magnetic pulses through a cushioned helmet to stimulate targeted regions of the prefrontal cortex, the company explained.

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The 510(k) clearance was supported by real-world evidence from 1,120 adolescents treated across 35 TMS centers in the US between 2012 and 2024. Participants received 36 sessions of either high-frequency (18 Hz) Deep TMS or intermittent theta-burst stimulation. Results demonstrated an average improvement of 12.1 points on the self-administered Patient Health Questionnaire-9 (PHQ-9) rating scale and a 66.1% response rate, defined as an improvement from baseline of 50% or greater, according to BrainsWay. The analysis also showed meaningful reductions in anxiety symptoms using the self-administered Generalized Anxiety Disorder (GAD-7) scale. Adverse events were consistent with previous adult studies, with the most common including headaches and local discomfort that were often mild and temporary, along with muscle twitching and jaw pain.

"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," Colleen Hanlon, PhD, VP of medical affairs at BrainsWay, said in a statement. "The 510(k) clearance was supported by our submission of one of the largest real-world adolescent neuromodulation datasets ever presented to the [agency], she added,which demonstrated compelling efficacy and safety in reducing depressive symptoms, as well as substantial improvements in comorbid anxiety."

The Treatment and The Challenge

The treatment requires daily 20-minute sessions over 4 to 6 weeks. While the therapy may take several weeks to improve MDD symptoms substantially, patients may notice earlier subtle changes such as increased alertness, higher energy levels during the day, or greater patience, according to the statement.

"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," Hadar Levy, BrainsWay's CEO, said. "This clearance will allow us to reach the broadest age range of any TMS system for the treatment of depression."

MDD impacts up to 5 million US adolescents a year in the US, according to a recent review,2 and among those, symptoms do not improve in approximately 30% who are treated with evidence-based therapy. Broadly defined, depression that is treatment resistant in this population has not responded to a 2-month trial of an antidepressant at a therapeutic dose or to 8 to 16 sessions of cognitive behavioral therapy.2 Importantly, approximately half of adult cases of depression have onset before the age of 18.3

Advances in Neuromodulation for Mental Health

Neuromodulation technologies for psychiatric conditions have evolved rapidly over the past decade, particularly as clinicians seek additional tools for individuals who do not respond to medication alone. TMS demonstrates effectiveness in approximately 50% of patients with major depressive disorder or obsessive-compulsive disorder who have not responded sufficiently to psychotherapy or medication.4 Meta-analyses of adjunctive repetitive TMS in treatment-resistant depression show response rates approaching 40% and remission rates of approximately 36%, with acutal TMS-treated participants more than twice as likely to respond compared with sham treatment.5

In 2023, the FDA issued 510(k) clearance for the SAINT protocol, which achieved 79% remission rates after just 5 days in randomized controlled trials.6 Beyond depression, neuromodulation research is expanding into post-traumatic stress disorder, generalized anxiety disorder, addiction and chronic pain, with investigators studying combinations of TMS with psychotherapy, digital monitoring tools or pharmacologic treatments to enhance durability of response.

The BrainsWay Deep TMS system is also indicated for the treatment of depressive episodes and for decreasing comorbid anxiety symptoms in adults with MDD who have failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The FDA has also cleared the device for treatment of obsessive-compulsive disorder, anxious depression, and smoking cessation, the company said.

References

1. BrainsWay. 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 19, 2025. https://investors.brainsway.com/news-releases/news-release-details/brainsway-receives-fda-clearance-deep-tmstm-adjunct-therapy
2. Ayvaci ER, Croarkin PE. Special populations: treatment-resistant depression in children and adolescents. Psychiatr Clin North Am. 2023;46(2):359-370. doi:10.1016/j.psc.2023.02.007
3. DeFilippis M, Wagner KD. Treatment-resistant depression in children and adolescents. In: Managing Treatment-Resistant Depression: Road to Novel Therapeutics. 2022:393-406.
4. Siddiqi S. Transcranial magnetic stimualtion today: not your grandomother's TMS. Psychiatric News. 2025;60(7). doi:10.1176/appi.pn.2025.07.7.33
5. Vida RG, Saghy E, BElla R, et al. Efficacy of repetitive transcranial magnetic stimulation (rTMS) adjunctive therapy for major depressive disorder (MDD) after two antidepressant treatment failures: meta-analysis of randomized sham-controlled trials. BMC Psychiatry. 2023;23(1):545. doi:10.1186/s12888-023-05033-y
6. FDA clears SAINT rapid-acting brain stimulation approach for those suffering from resistant major depression. News release. Brain & Behavior Research Foundation. August 11, 2023. Accessed November 19, 2025. https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major