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.

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%. 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," said Dr. Colleen Hanlon, VP of Medical Affairs at BrainsWay Ltd. "The 510(k) clearance was supported by our submission of one of the largest real-world adolescent neuromodulation datasets ever presented to the U.S. FDA, which demonstrated compelling efficacy and safety in reducing depressive symptoms, as well as substantial improvements in comorbid anxiety."

The treatment requires daily 20-minute sessions over four to six 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.

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

The BrainsWay Deep TMS system is now 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, and as adjunct therapy for adolescent patients aged 15 to 21. The FDA has also cleared the device for treatment of obsessive-compulsive disorder, anxious depression, and smoking cessation. With approximately 5 million adolescents in the United States estimated to have experienced a major depressive episode within the past year, the clearance addresses a significant unmet need in the MDD patient population.