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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Both high-frequency (18Hz) and intermittent theta-burst (iTBS) Deep TMS protocols were represented in the submission.
According to results measured by the Patient Health Questionnaire-9 (PHQ-9), after 36 treatment sessions patients achieved an average 12.1-point improvement, with a response rate of 66.1%.
Response was defined as at least 50% improvements from baseline scores.
The study also found notable decrease in the symptoms of anxiety, as measured by the Generalised Anxiety Disorder-7 (GAD-7) scale.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSafety outcomes were in line with those earlier reported in adult trials.
The TMS System is now indicated for use in treating depressive episodes and for reducing comorbid anxiety symptoms in adult patients with MDD who have not benefited sufficiently from prior antidepressant medication in their current episode and for adolescents.
BrainsWay CEO Hadar Levy said: “We are excited at the opportunities this clearance can bring, for both the young people suffering from this often debilitating condition, and for their parents who have struggled for so long to find treatment solutions that can bring some joy and hope back into their family life.
“With approximately five million adolescents in the US estimated to have experienced a major depressive episode within the past year, this represents a significant milestone for us to be able to address an important segment of the MDD patient population.
“Clinicians can now treat both adults and adolescents using the same Deep TMS system and established stimulation protocols.”
