NeuroSigma set to commence phase III trial

Tuesday, July 30, 2013

NeuroSigma, a Los Angeles-based medical device company, has announced conditional approval by the FDA of its IDE application to commence a phase III trial of the Monarch eTNS System for treatment of drug resistant epilepsy. The company is planning to conduct a multi-center trial at medical institutions in the U.S., Europe and Canada.  The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre-Market Approval (PMA) application to the FDA.

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