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 Trigeminal Nerve Stimulation (eTNS) system for the treatment of neurological and neuropsychiatric disorders.
NeuroSigma senior medical advisor and UCLA School of Medicine depression research and clinic program director Ian Cook said, "As a novel and non-invasive therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression, post-traumatic stress disorder (PTSD), and epilepsy, and offers the potential to significantly improve the lives of millions of people without the side-effects common to drug treatment."
NeuroSigma is planning to submit the technical file in pursuit of European regulatory approval for its first generation eTNS system.
The company said, after receiving CE mark, it will start marketing and distributing its new therapy for epilepsy and depression in Europe.