Neuronetics NeuroStar receives FDA clearance for adolescent depression — first TMS cleared for under-18s

Summary

Neuronetics received FDA 510(k) clearance for NeuroStar TMS therapy in adolescents aged 15-21 with major depressive disorder, making it the first TMS system cleared for use in patients under 18. The clearance was supported by a clinical study of 103 adolescents showing 58% response rate at 6 weeks.