NeuroXess 'Sanquan' BCI Enters CMDE Innovative Medical Device Review Program

Summary NeuroXess announced that its self-developed implantable brain-computer interface system for hand motor function compensation — the 'fully implanted, fully wireless, fully functional' ('Sanquan') system — has passed public notice and formally entered the innovative medical device special review program of the National Medical Products Administration's Center for Medical Device Evaluation (CMDE), commonly known as the green channel. The company describes it as the first subdural implantable flexible BCI product in China to enter the program. The system began a GCP registration clinical trial at Huashan Hospital, Fudan University on July 7, 2026, run as a multicentre study across 15 Class III hospitals nationwide, with trial data intended to support a Class III medical device registration application with the NMPA. The system remains in the review and clinical-trial stage and has not yet been approved for market; the registration timeline reflects company statements and remains subject to regulatory notice.