Magnus Medical has secured 510(k) clearance for the SAINT Neuromodulation System from the US Food & Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults.

The 510(k) clearance is for the non-invasive, individualised and precise treatment in patients who could not see satisfactory improvement from prior antidepressant medications in the current episode. It follows the breakthrough device designation granted by the FDA to the neurostimulation technology in October 2021.

Magnus Medical co-founder and CEO Brett Wingeier said: “We are now at the forefront of an enormous improvement in the care of treatment-resistant depression, thanks to the work of the Magnus team and all those whose efforts have led to the SAINT technology.

“Today’s FDA’s clearance for the SAINT Neuromodulation System is a major milestone in our long-term journey to restore and sustain mental health.

“More broadly, we look forward to seeing this work make a positive impact for the millions of people affected by neuropsychiatric disease.”

Wingeier said that Magnus Medical expects to commercially launch the SAINT Neuromodulation System starting from 2023 on a limited basis.

The SAINT Neuromodulation System integrates hardware, software, and cloud computing to find the ideal anatomic target for focused neuromodulation in MDD patients. The system uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm for identifying the target, said Magnus Medical.

According to the medical device company, this approach is specifically suited to each person’s brain connectivity and is delivered in an expedited timeframe.

The results of a double-blinded randomised controlled trial (RCT) that assessed the SAINT system were published in the American Journal of Psychiatry. The trial demonstrated that 79% of those receiving active treatment had remission from their depressive symptoms, when compared to 13% in the sham treatment arm.