China’s National Medical Products Administration (NMPA) has approved the registration of an Implantable Brain Computer Interface (BCI) for Hand Motor Augmentation developed by Neuracle Technology (Shanghai) Co., Ltd., marking the world’s first market launch of an invasive BCI medical device.
The device, named “NEO,” is intended for patients aged 18 to 60 with quadriplegia caused by cervical spinal cord injuries who are unable to perform finger grasping movements.
By implanting a coin-sized invasive device, the system collects and decodes patients’ brain signals in real time, enabling them to control a pneumatic glove to perform actions such as grasping objects, picking up items, and drinking water.
The product uses an epidural implantation approach to ensure high signal quality while avoiding direct brain tissue damage. Its wireless power supply and communication design allow long-term use, and patients can operate the system independently at home about one month after surgery.
So far, the device has been applied in 36 clinical procedures, including four feasibility trials and 32 multi-center Good Clinical Practice (GCP) clinical trials, with participants showing varying degrees of improvement in hand function and, in some cases, signs of neural remodeling.
The BCI sector has been identified as a future industry in China’s government work report and is a key priority for Shanghai. The municipality has fostered 60 innovative enterprises dedicated to BCI research, with three invasive products under the NMPA’s special review and one designated as a Breakthrough Therapy by the U.S. Food and Drug Administration, according to the Science and Technology Commission of Shanghai Municipality.