NeuroSigma wins an FDA green light for Phase III clinical trials
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 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.