China's First Subdural Cortical Surface Brain-Computer Interface Enters Class III Device Registration Trial

NeuroXess announced that its self-developed implantable brain-computer interface hand motor function compensation system has officially launched a GCP registration clinical trial at Huashan Hospital, Fudan University, making it the first subdural cortical surface implantable brain-computer interface product in China to enter the Class III medical device registration clinical stage. China has more than 3 million existing spinal cord injury patients, with about 90,000 to 100,000 new cases each year. Patients with quadriplegia caused by cervical spinal cord injury depend entirely on others for daily living, and brain-computer interface is currently the core technological path that allows such patients to achieve functional reconstruction.

The registration trial is led by the team of Professor Mao Ying at Huashan Hospital as principal investigator, and adopts a multicenter model involving 15 tertiary hospitals in multiple locations across China. The product uses a subdural implantation approach, attaching flexible electrodes to the surface of the cerebral cortex without penetrating brain tissue, while its split design places the battery and other high-heat generating units under the skin of the chest, effectively avoiding high-temperature risks.