NeuroSigma receives FDA breakthrough device designation for Monarch eTNS system

NeuroSigma

22 February 2022 - Monarch eTNS recognised as novel device for drug resistant epilepsy.

NeuroSigma today announced FDA breakthrough device designation for its Monarch eTNS System for "adjunctive use for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more antiepileptic medications.”

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Michael Wonder

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Michael Wonder