Magnus Medical SAINT receives FDA 510(k) clearance for rapid-remission depression treatment

Magnus Medical/SAINT

The FDA cleared SAINT for treatment of Major Depressive Disorder with Breakthrough Device Designation. The 5-day protocol demonstrated 79% remission rates with median time to remission of 2.6 days, compared to 6-9 weeks for standard TMS.

• FDA 510(k) clearance enables commercial deployment across US hospitals and clinics.
• Prior Breakthrough Device Designation (October 2021) accelerates approval timelines.
• Clinical trial data: 79% remission rate, median remission within 2.6 days, versus 13% in sham control.