China has granted the world’s first market approval for an invasive brain–computer interface (BCI) medical device, marking a significant step in the clinical application of neurotechnology designed to help patients with severe paralysis.
China’s National Medical Products Administration (NMPA) approved the registration of the implantable device developed by Neuracle Technology (Shanghai) Co., Ltd., allowing it to enter the medical market and clinical application stage.
The device, known as “NEO,” is designed for patients aged 18 to 60 who suffer from quadriplegia caused by cervical spinal cord injuries and are unable to perform basic hand movements such as grasping objects.
Device enables movement through brain signals
The system works by implanting a coin-sized device that captures and decodes brain signals in real time. These signals are then used to control a pneumatic glove, allowing patients to perform actions such as grasping objects, lifting items or drinking water.
Developers said the technology uses an epidural implantation approach, which enables high-quality signal acquisition while avoiding direct contact with brain tissue.
The device also uses wireless power and communication systems, allowing patients to use the technology for extended periods after a single surgical procedure. According to the developer, patients can begin operating the system independently at home about one month after implantation.
Clinical trials show improvement in hand function
So far, the device has been tested in 36 clinical procedures, including feasibility trials and multi-center Good Clinical Practice (GCP) studies.
According to researchers, all participating patients showed varying degrees of improvement in grasping ability. Some patients also displayed signs of neural recovery and partial restoration of certain neurological functions.
Brain–computer interface sector gaining policy support
The brain–computer interface sector has been identified as a future technology priority in China’s latest government work report.
Shanghai has emerged as a key research hub for the technology. According to the Science and Technology Commission of Shanghai Municipality, the city currently hosts around 60 companies involved in BCI research and development.
Several invasive BCI products developed by these companies have entered the NMPA’s special review process for innovative medical devices. One product has also been designated as a Breakthrough Therapy by the United States Food and Drug Administration.
Experts say advances in BCI technology could open new possibilities for treating neurological injuries and restoring movement in patients with severe paralysis.
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