FDA expands BrainsWay Deep TMS indication to adolescents with MDD
The US Food and Drug Administration has granted a 510(k) clearance broadening the labelled use of BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) system to include adjunctive treatment for adolescents aged 15–21 with major depressive disorder (MDD).
Evidence behind the decision
The clearance was supported by BrainsWay's submission of real‑world evidence comprising 1,120 adolescents treated at 35 US TMS centres between 2012 and 2024. The submission included treatments using both high‑frequency (18 Hz) Deep TMS protocols and intermittent theta‑burst stimulation (iTBS) protocols.
Key efficacy findings
Measured with the Patient Health Questionnaire‑9 (PHQ‑9), adolescents achieved a mean improvement of 12.1 points after 36 treatment sessions. The observed response rate was 66.1%, where response was defined as a ≥50% reduction from baseline PHQ‑9 score. Investigators also reported a meaningful reduction in anxiety symptoms measured by the Generalised Anxiety Disorder‑7 (GAD‑7) scale.
Safety and clinical implications
Reported safety outcomes in the adolescent cohort were consistent with safety data previously observed in adult Deep TMS trials. The Deep TMS System is now indicated to treat depressive episodes and to reduce comorbid anxiety symptoms in adult patients with MDD who have not adequately benefited from prior antidepressant medication in their current episode, and the indication has been extended to include adolescents aged 15–21.
BrainsWay CEO Hadar Levy: "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."
Levy noted that with an estimated five million US adolescents having experienced a major depressive episode in the past year, the expanded clearance represents a significant milestone for addressing an important segment of the MDD population. She added that clinicians can now treat both adults and adolescents using the same Deep TMS system and established stimulation protocols.
Source and disclaimer
This report is based on information originally published by Medical Device Network, a GlobalData‑owned brand. The information is provided for general informational purposes and is not medical advice. Patients and caregivers should consult qualified healthcare professionals before making treatment decisions.
