Neurosoft Bioelectronics, a start-up developing implantable brain-computer interfaces received ISO 13485:2016 certification for its quality system. This is a great step toward making this cutting-edge product, called SOFT ECoG, closer to clinical trials and regulatory approval. This stretchable and high-density subdural electrode is set to revolutionize brain monitoring and stimulation for patients with drug-resistant epilepsy and brain tumors. The SOFT ECoG will also pave the way for future therapies, starting with closed-loop cortical neuro-stimulation for severe tinnitus. This major milestone was achieved by implementing a medical-grade production line at the Campus Biotech, in collaboration with the Neural Microsystems Platform (NMP). Congrats!
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