FDA Executive Summary of NeuroStar TMS System

January 26, 2007 FDA Executive Summary of NeuroStar TMS System The NeuroStar TMS System was presented to the U.S. Food and Drug Administration (FDA) Neurological Devices advisory panel as a treatment for major depressive disorder. The NeuroStar device employs repetitive transcranial magnetic stimulation (TMS) to stimulate neurons in the brain that are linked to depression. The therapy is performed in an outpatient setting and is non-invasive. The test results of a six-week, double-blind, placebo (sham)-controlled, monotherapy clinical trial indicated that the NeuroStar System therapy was well-tolerated by the 325 trial participants. The discontinuation rate . . .