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Sponsor Executive Summary Neuronetics, Inc. 19 December 2006 ... - fda

Sponsor Executive Summary Neuronetics, Inc. 19 December 2006 ... - fda-2025

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The document provides a comprehensive overview of the NeuroStar System, a device developed by Neuronetics for the treatment of Major Depressive Disorder (MDD) using Transcranial Magnetic Stimulation (TMS). It details the system's safety and efficacy based on clinical studies, including randomized controlled trials and open-label extensions. The findings indicate that TMS therapy is effective in reducing depression symptoms, with a favorable risk-to-benefit ratio compared to traditional antidepressant medications and Electroconvulsive Therapy (ECT). The document also discusses regulatory considerations for FDA clearance, demonstrating substantial equivalence to ECT devices. Overall, it supports the use of the NeuroStar System as a viable treatment option for patients with MDD.

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