Resources for Food and Drug Administration (FDA)

FDA OKs TMS Depression Device

www.webmd.com

The FDA has cleared the NeuroStar TMS brain-stimulating device for treating depressed adults for whom one antidepressant has failed to work. It's the first transcranial magnetic stimulation (TMS) device to pass FDA muster. An FDA spokesperson tells WebMD that because the NeuroStar device is not implanted and carries only "moderate" risk, the FDA needed to only "clear" the device and not formally "approve" it. The clearance comes nearly two years after a January 2007 FDA advisory panel said clinical trials failed to establish that the device was clinically effective. Although TMS-treated patients were twice as likely as sham-treated patients to show clinical benefit, some panel members said this effect was "small," "borderline," "marginal," and "of questionable clinical significance."

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