BrainsWay's Deep TMS cleared for depression in people aged 15 to 21
The FDA clearance for adolescent depression as an add-on therapy was based on real-world data from more than 1,100 young patients.
The FDA has cleared BrainsWay’s Deep TMS as an add-on therapy for major depressive disorder in young people aged 15 to 21. The clearance drew on real-world data from 1,120 adolescents treated at 35 US clinics between 2012 and 2024. After 36 sessions, depression scores improved by an average of 12.1 points, and 66.1% of patients met the response threshold.
Treatment options for adolescent depression are limited, and the decision broadens access to non-drug brain stimulation for this group.