IN a landmark advance for neurorestorative medicine, an implantable brain-computer interface (BCI) system for hand motor function has been successfully used in a clinical procedure at Huashan Hospital, affiliated with Fudan University in Shanghai. The surgery marks the inaugural real-world application of the Neural Electronic Opportunity (NEO) system — the first implantable BCI Class III medical device to receive global market authorization. The surgery followed the device’s official market approval on March 13 and represents the first prescription issuance for the NEO system in China. According to hospital officials, the patient remains in stable condition postoperatively. Intraoperative monitoring confirmed that the epidural electroencephalogram signals captured by the system were stable and of high quality, validating the device’s real-time performance. Developed by Neuracle Medical Technology (Shanghai) Co., Ltd., the NEO system transitions BCI technology from laboratory and trial settings into routine clinical practice. With this regulatory milestone, the device is now available as a therapeutic option for eligible patients, offering new hope to millions worldwide living with paralysis due to spinal cord injuries. Severe spinal cord injury often impairs hand grasping ability, and traditional pharmacological or rehabilitative approaches yield limited results for many patients. The recipient of this pioneering surgery — a patient who sustained a spinal cord injury in a car accident a decade ago — had experienced persistent hand dysfunction and restricted daily living activities, with no further improvement despite standardized rehabilitation. Following rigorous screening and multidisciplinary evaluation, in line with the product’s registered indications, the patient was deemed a suitable candidate for the implantation. The NEO system functions by capturing and decoding epidural EEG signals to discern motor intention, thereby establishing a neural bridge between the brain and an external functional compensation device. This assistive technology specifically supports hand-grasping movements, with clear potential to enhance the patient’s independence and quality of life in everyday activities.(SD-Agencies) |