The US Food and Drug Administration (FDA) has granted 510(k) clearance expanding the label of BrainsWay’s Deep Transcranial Magnetic Stimulation (TMS) system, allowing its use as an adjunct therapy for people aged 15 to 21 years with major depressive disorder (MDD).

This clearance is based on data submitted by BrainsWay, which included real-world evidence from 1,120 adolescents who received treatment at 35 US TMS centres between 2012 and 2024.

Both high-frequency (18Hz) and intermittent theta-burst (iTBS) Deep TMS protocols were represented in the submission.