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FDA Clears BrainsWay's Deep TMS System for Adolescent Depression Treatment
14 Nov
Summary
- FDA grants 510(k) clearance for BrainsWay's Deep TMS system to treat major depressive disorder in ages 15-21
- Real-world data from 1,120 adolescents shows 66.1% response rate and 12.1-point improvement on PHQ-9 scale
- Clearance allows treating both adults and adolescents with the same Deep TMS system
In a significant development, the US Food and Drug Administration (FDA) has granted 510(k) clearance to expand the label of BrainsWay's Deep Transcranial Magnetic Stimulation (TMS) system. This clearance allows the system to be used as an adjunct therapy for people aged 15 to 21 years with major depressive disorder (MDD).
The clearance is based on real-world evidence submitted by BrainsWay, which included data from 1,120 adolescents who received treatment at 35 US TMS centers between 2012 and 2024. Both high-frequency (18Hz) and intermittent theta-burst (iTBS) Deep TMS protocols were used in the treatment. According to the results, patients achieved an average 12.1-point improvement on the Patient Health Questionnaire-9 (PHQ-9) scale, with a response rate of 66.1%. The study also found a notable decrease in anxiety symptoms, as measured by the Generalised Anxiety Disorder-7 (GAD-7) scale.
This milestone is particularly significant, as it allows clinicians to now treat both adults and adolescents using the same Deep TMS system and established stimulation protocols. BrainsWay's CEO, Hadar Levy, expressed excitement about the opportunities this clearance can bring, stating that it represents an important step in addressing the needs of the approximately 5 million adolescents in the US estimated to have experienced a major depressive episode within the past year.
