China’s drug regulator announced on Friday that it has approved a brain-computer interface (BCI) system designed to help restore hand movement, marking the world’s first commercial approval of a BCI device.
- The device was developed by Borui Kang Medical Technology (Shanghai) and is intended to help people with different forms of paralysis regain movement and improve their ability to communicate.
- The device is designed for patients with quadriplegia caused by cervical spinal cord injuries, helping them regain hand-grasping ability through a special glove.
- It is an invasive brain-computer interface system, meaning electrodes are implanted directly into the brain rather than placed on its surface. The device uses minimally invasive extradural implantation and works with wireless technology.
- China’s drug regulator, National Medical Products Administration, said BCI technologies like this have been given priority and noted that the sector has been identified as a “future industry” in Beijing’s latest five-year plan released last week.
- China could see brain-computer interface (BCI) technology move into practical public use within the next three to five years as the technology develops further, a leading BCI expert told Reuters. The move comes as Beijing works to catch up with U.S. startups such as Neuralink, founded by Elon Musk.
- Patients eligible for the device must be between 18 and 60 years old and have a specific type of spinal cord injury. Their diagnosis must be at least one year old, and they must have remained in a stable condition for six months after standard treatment. Patients must also be unable to grasp objects with their hands but still have some upper-arm movement.
- According to the regulator, clinical trial results showed significant improvement in hand-grasping ability among participants, helping improve their overall quality of life.
