FDA Expands Clearance for Deep TMS Therapy to Adolescents With Major Depression

The US Food and Drug Administration (FDA) has granted 510(k) clearance to expand BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) system for use in adolescents aged 15–21 with major depressive disorder (MDD). Previously cleared for adults, the system can now be used as an adjunct therapy for younger patients who have not responded adequately to antidepressant medications.

The decision is supported by real-world data from 1,120 adolescents treated at 35 US TMS centres between 2012 and 2024. Both 18Hz high-frequency and intermittent theta-burst (iTBS) protocols were included. Patients showed an average 12.1-point improvement on the PHQ-9 after 36 sessions, with a 66.1% response rate, defined as at least a 50% reduction from baseline scores. Anxiety symptoms also improved on the GAD-7 scale. Safety results were consistent with previous adult studies.

With an estimated five million US adolescents experiencing a major depressive episode in the past year, the expanded indication allows clinicians to use the same Deep TMS system and treatment protocols for both adults and adolescents.

16-11-2025