Brainsway’s Deep TMS device granted FDA clearance in Major Depressive Disorder

BrainsWay (BWAY) announced that the FDA has granted a label expansion for the Deep Transcranial Magnetic Stimulation, or Deep TMS, system making the treatment available as an adjunct therapy for adolescents aged 15 to 21 years suffering from major depressive disorder, or MDD. The 510(k) clearance followed BrainsWay’s submission of data including real-world evidence collected from 1,120 adolescents treated across 35 TMS centers in the U.S. between 2012 and 2024. Results demonstrated, following 36 treatment sessions, an average improvement of 12.1 points and a 66.1% response rate. In addition, meaningful reductions in anxiety symptoms were observed using the self-administered Generalized Anxiety Disorder scale, consistent with prior adult studies. Safety outcomes were consistent with previous adult studies.