China’s drug regulator has granted approval for a pioneering brain-computer interface (BCI) system, marking the world’s first commercial authorisation for such a device. The technology, developed by Borui Kang Medical Technology (Shanghai), is designed to restore hand-movement capabilities in individuals suffering from paralysis.
Specifically, the system targets patients with quadriplegia resulting from cervical spinal cord injuries, enabling them to regain hand-grasping ability through the use of a specialised glove.
This innovative product is an invasive BCI system, meaning electrodes are directly implanted into the brain rather than resting on its surface. It employs minimally invasive extradural implantation, utilising wireless technology for its operation.
The National Medical Products Administration highlighted that BCI products, including this newly approved device, have been prioritised. The sector was recently designated a “future industry” within Beijing’s latest five-year plan, unveiled last week, underscoring its strategic importance.
China could see brain-computer interface (BCI) technology move into practical public use within three to five years as products mature, a leading BCI expert told Reuters last week, as Beijing races to catch up with U.S. startups including Elon Musk’s Neuralink.
Eligible patients for the product must be aged 18 to 60 and suffer from a specific kind of spinal cord injury. Their diagnosis must be at least a year old, and they must be in a stable condition for six months following standard treatment. Patients must be unable to grasp with their hands but retain some upper‑arm function.
Clinical trial data showed significant improvement in hand‑grasping ability among participants, the regulator said, adding that the gains helped enhance patients’ quality of life.
