Magnus Medical Received 510(k) Clearance for Its Saint Neuromodulation System

Magnus Medical received 510(k) clearance from the FDA for its Saint Neuromodulation System for the treatment of adults with major depressive disorder who haven’t achieved satisfactory improvement from prior antidepressant medications in the current episode.

Magnus Medical said the system integrates hardware, software and cloud computing, and uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm to identify the optimal anatomic target for focused neuromodulation in people with major depressive disorder.

Results from a trial published in the American Journal of Psychiatry showed that 79 percent of people in the active treatment arm of the study entered remission from their depression compared to 13 percent in the sham treatment arm, said the company.

The system also received Breakthrough Device designation from the FDA.