FDA Grants NeuroStar Clearance As First-Line Add-On Treatment For Adolescents With Depression  

Neuronetics said the FDA granted clearance of its NeuroStar Advanced Therapy for use as an adjunct for the treatment of major depressive disorder (MDD) in adolescent patients aged 15-21.  The company said this is the fourth FDA-cleared indication for the transcranial magnetic stimulation (TMS) treatment provided by the NeuroStar system.  

Neuronetics said the clearance was based on data collected through NeuroStar's proprietary TrakStar platform. The data analysis, among 1,169 adolescents, found 78% of NeuroStar users achieved clinically meaningful improvement in their depression severity. 

NeuroStar is indicated for the treatment of . . .