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NeuroSigma wins an FDA green light for Phase III clinical trials

Mon, 07/29/2013 - 2:25pm
Mass Device

California medical device maker NeuroSigma lands FDA investigational device exemption to launch Phase III studies of its epilepsy treatment in support of U.S. approval.

NeuroSigma

NeuroSigma is one step closer to bringing its epilepsy treatment to U.S. markets with FDA approval to begin its Phase III clinical studies.

Currently only available for investigational use in the U.S., NeuroSigma's Monarch eTNS system is already on the shelves in Europe and Canada. Earlier studies have shown a 50% reduction in seizures for 2/5 of epilepsy patients treated, NeuroSigma said.

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