Thursday, April 17, 2014

FDA Clearance Expands Indication for NeuroStar TMS Therapy


Neuronetics Announces FDA Clearance to Expand Indication for NeuroStar TMS Therapy to Broader Population of Adults with Major Depressive Disorder

Label expansion is supported by largest body of clinical data of any Transcranial Magnetic Stimulation (TMS) system for depression



MALVERN, PA, April 7 , 2014
Neuronetics, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its premarket notification to expand the indication for its novel, non -drug depression treatment, NeuroStar TMS Therapy, to treat adult patients with

Major Depressive Disorder (MDD) who have failed to benefit from any number
 of antidepressant medications. The label expansion was based on new clinical data from a large, prospectively randomized, sham controlled clinical trial that found that TMS delivered by the NeuroStar TMS Therapy System produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham treatment.

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