FDA clears neuromod system for treating depression from Magnus Medical

[Image from Magnus Medical]Magnus Medical announced today that it received FDA 510(k) clearance for its Saint neuromodulation system.

Burlingame, California-based Magnus designed Saint for the treatment of major depressive disorder (MDD). It treats adults who fail to achieve satisfactory improvement from prior antidepressant medications in the current episode.

The individualized, rapid-acting, non-invasive neurostimulation platform demonstrated the potential to be a reproducible, rapid and highly effective treatment for severe, refractory depression in a broader clinical setting. It received FDA breakthrough device designation in October 2021.

Saint combines advanced imaging technologies and personalized targeting and novel stimulation patterns. It uses structural and functional MRI to inform a proprietary algorithm. The algorithm identifies the optimal anatomic target for focused neurostimulation in people with MDD.

Results of a trial published in t…

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FDA grants breakthrough nod to Magnus Medical’s neurostim treatment for depression

Magnus Medical announced today that it received FDA breakthrough device designation for its neurostimulation technology and raised $25 million.

Burlingame, California-based Magnus designed its individualized, rapid-acting, non-invasive neurostimulation platform to treat major depressive disorder (MDD) for people who have not improved sufficiently from antidepressant medication or other treatments.

Magnus based its system on SAINT technology, which was licensed exclusively to the company from Stanford University for commercialization, according to a news release.

An article published online by the American Journal of Psychiatry included results from an investigational randomized controlled trial evaluating SAINT that demonstrated the potential to be a reproducible, rapid and highly effective treatment for severe, refractory depression in a broader clinical setting.

According to Magnus Medical Co-Founder & CSO Dr. Brandon Bentzley, the study sho…

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