BrainsWay FDA clears Deep TMS for adolescent depression November 2025 — first drug-free brain stimulation for teens aged 15-21
Summary
BrainsWay received FDA clearance for Deep TMS for the treatment of severe depression in adolescents aged 15-21 in November 2025, making it the first drug-free brain stimulation treatment cleared for this age group. Parents are often hesitant to prescribe heavy antidepressants to teenagers due to side effect profiles and black box warnings. BrainsWay's Deep TMS offers a non-drug, non-pharmacological alternative for the most treatment-resistant adolescent depression cases. 2026 represents the first full year of commercialization of this new indication, building on BrainsWay's existing OCD (2018) and TRD (2013) clearances.
Why it matters
BrainsWay clearing Deep TMS for adolescent depression fills a significant gap in the mental health treatment landscape: teenagers with severe depression who have not responded to SSRIs or cannot tolerate antidepressant side effects currently have no approved non-drug options. The FDA clearance for ages 15-21 is the most commercially accessible adolescent mental health neuromodulation approval ever granted — parents who would refuse pharmacological antidepressants for their children may readily accept a non-drug TMS treatment.
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