Meeting of the minds
This article was originally published in The Gray Sheet
Executive Summary
Neuronetics' 510(k) for NeuroStar transcranial magnetic stimulation system will go before FDA's Neurological Devices Panel Oct. 31 as a potential treatment for major depressive disorder. A 301-patient, randomized, sham-controlled trial found a 25% response - double the control group - from patients treated with the nonimplanted device, which administers a magnetic field in short pulses to a patient's head (1"The Gray Sheet" June 19, 2006, p. 7). That day, the panel also will review post-approval data for two unidentified "recently approved neurological device" PMAs...