CTMSS Press Release: Regarding FDA Clearance of SAINT Neuromodulation System



Ashleigh Servadio, MSC
Executive Director
Clinical TMS Society
(845) 392.3238 phone
(559) 227.1463 fax

CTMSS Press Release: Regarding FDA Clearance of SAINT Neuromodulation System -

Fresno, CA. September 16, 2022 – Last week, Magnus Medical Inc, announced that the U.S. Food & Drug Administration (FDA) has cleared the SAINTTM (Stanford Accelerated Intelligent Neuromodulation Therapy) Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve adequate improvement from antidepressant medications.

The Clinical TMS Society is encouraged by the new FDA clearance and SAINT’s rapid and excellent results found in its clinical trials. Our society would like to highlight the components of Magnus Medical’s SAINT Neuromodulation System, as well as how it differs from other FDA cleared Transcranial Magnetic Stimulation (TMS) protocols for depression. The SAINT approach uses structural magnetic resonance imaging (MRI), as well as a special type of brain MRI called a functional connectivity MRI to identify an individualized treatment target. It also delivers 50 treatments over the course of five days (10 treatments per day). Clinics offering SAINT Neuromodulation treatment would require patients to undergo both structural and functional connectivity MRIs, would upload those scans to specialized cloud-based software which identifies the treatment targets, and would use special equipment (neuronavigational equipment) to
navigate the TMS coil over the individualized treatment target within each patient’s brain for each treatment.

The Clinical TMS Society’s Clinical Standards Committee is currently updating a more comprehensive statement about the SAINT Neuromodulation System, which will be released shortly. The table in the attachment below highlights the differences between the newly FDA-cleared SAINT Neuromodulation System and the 2019 FDA-cleared intermittent theta burst stimulation (iTBS) protocol.

For more information on the Clinical TMS Society please call (845) 392.3238 or visit clinicaltmssociety.org.

CLICK HERE to view the full Press Release.