NeuroSigma has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a Phase III pivotal trial of its Monarch eTNS System. Designed to treat the drug resistant epilepsy, the ...
Tags: Device Trial, NeuroSigma
Los Angeles-based NeuroSigma, a developer of early stage neuromodulation technologies, has won ISO 13485: 2003 certification. The certificate indicates that the company meets the quality standards to design, and manufacture its external ...
Tags: NeuroSigma, neuromodulation technologies, ISO certification, eTNS
NeuroSigma has obtained CE mark approval for its external Trigeminal Nerve Stimulation (eTNS) system, Monarch, designed for the treatment of epilepsy and major depressive disorder in adults and children of 9 years and older. The eTNS ...
Tags: NeuroSigma, eTNS, FDA