Magnus Medical recently received U.S. Food and Drug Administration (FDA) approval for its neuromodulation system used to treat major depressive disorder (MDD). The 510(k) clearance is for the non-invasive, individualized treatment for patients who did not improve from prior antidepressant medications in the current episode, and follows the breakthrough device designation granted by the FDA to the neurostimulation technology in October 2021. The results of a double-blinded randomized controlled trial (RCT) that assessed the SAINT Neuromodulation System were published in the American Journal of Psychiatry. The trial demonstrated that 79% of those receiving active treatment had achieved remission from their depressive symptoms when compared to 13% in the sham treatment arm. This neuromodulation system uses structural and functional magnetic resonance imaging (fMRI) to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD. According to the medical device company, this approach is delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.
>> Magnus Medical, Inc. Press Release