Neuronetics Gets Expanded 510(k) Clearance for NeuroStar TMS Device

Neuronetics has gained an expanded 510(k) clearance from the FDA for its NeuroStar transcranial magnetic stimulation (TMS) system for treating adult patients with major depressive disorder who have anxiety symptoms.

The system, which works by stimulating neurons in the area of the brain that controls mood, was previously cleared for treatment of drug-resistant depression and obsessive-compulsive disorder. The expanded clearance is for patients with anxiety who failed to achieve satisfactory improvement from previous antidepressant medication treatment in their current episode.

The expanded clearance was based on real-world data from 664 patients in which 65.5 percent of treated patients achieved a clinically meaningful response.

The company’s proprietary database, TrakStar, contains real-world data from patients treated with NeuroStar at more than 1,000 centers.