FDA Clears The Neuronetics’ NeuroStar TMS System For Treatment Of Anxious Depression

Neuronetics, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared its NeuroStar transcranial magnetic stimulation (TMS) system as treatment for a new indication, anxious depression. The system, called NeuroStar Advanced Therapy for Mental Health, is also cleared for primary treatment of drug-resistant major depressive depression (MDD) and for adjunct treatment of obsessive-compulsive disorder (OCD). Anxious depression affects more than 50% of people with MDD.

In granting clearance for this new indication, the FDA accepted Neuronetics’ use of real-world data analyzed from NeuroStar’s proprietary TrakStar® platform. The TrakStar database contains digital data from patients . . .