FDA Green Lights First At-Home Brain-Stimulation Device for MDD: Daily Dose

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On November 19, 2025, we reported on the FDA clearance of BrainsWay's Deep TMS (Transcranial Magnetic Stimulation) system for use as adjunct therapy in adolescents aged 15 to 21 years with major depressive disorder (MDD).

The approval

The system is the first TMS device approved for the treatment of depression among individuals aged 15 to 86 years.

The 510(k) clearance was supported by real-world evidence from 1120 adolescents treated across 35 TMS centers in the US between 2012 and 2024. Participants received 36 sessions of either high-frequency (18 Hz) Deep TMS or intermittent theta-burst stimulation. Results demonstrated an average improvement of 12.1 points on the self-administered Patient Health Questionnaire-9 (PHQ-9) rating scale and a 66.1% response rate, defined as an improvement from baseline of 50% or greater, according to BrainsWay. The analysis also showed meaningful reductions in anxiety symptoms using the self-administered Generalized Anxiety Disorder (GAD-7) scale. Adverse events were consistent with previous adult studies, with the most common including headaches and local discomfort that were often mild and temporary, along with muscle twitching and jaw pain.

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