NeuroStar Advanced Therapy receives FDA clearance

Neuronetics announced clearance from the U.S. Food and Drug Administration for NeuroStar Advanced Therapy for use as an adjunct for the treatment of major depressive disorder in adolescent patients aged 15-21. NeuroStar is the first and only transcranial magnetic stimulation treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar. The FDA’s decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar’s proprietary TrakStar platform. This platform provided crucial insights into the treatment’s effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity. The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.