FDA Grants Breakthrough Device Designation for Magnus’ SAINT Neuromodulation System

Brain stimulation medtech company Magnus Medical has been granted a 510(k) for its SAINT Neuromodulation System. The system was approved for treating adults suffering from major depressive disorder (MDD) that have not achieved satisfaction in their improvement from previous antidepressant medication in the current episode. In a double-blinded randomized controlled trial (RCT) with results recently published by The American Journal of Psychiatry, SAINT incorporation saw 79% of participants in the active treatment group enter remission from their depression. This result was truly outstanding, particularly when juxtaposed with the 13% rate seen in the placebo group.

In granting its coveted Breakthrough Device Designation, the FDA has chosen a healthcare solution that addresses a sore spot in the wellness of the U.S. population: mental health. Treatment for severe depression is a mixed bag, and SAINT’s proprietary algorithm leveraging structural and functional magnetic resonance imaging (MRI) could transform the space.

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"Magnus' SAINT technology is groundbreaking and could help many patients with major depressive disorder who have not responded to treatment with antidepressants," said Dr. Alan F. Schatzberg, the Kenneth T. Norris Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University. “The technology could result in a fundamental change in the treatment approach to patients with refractory MDD and has the potential to reduce both the morbidity and mortality associated with the disorder."

The SAINT approach entails identifying the ideal anatomic target for focused neurostimulation in individuals with MDD. Delivery is on an accelerated timeline for optimal treatment depending on each patient’s unique brain connectivity.