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China's National Medical Products Administration has approved what it describes as the world's first commercially available implantable brain-computer interface (BCI), clearing a solution designed to help restore hand movement in patients with severe paralysis.
WHAT IT'S ABOUT
The device, developed by Shanghai-based Borui Kang Medical Technology, is an invasive BCI system that captures neural signals through implanted electrodes in the brain and translates them into commands to control an external assistive glove device.
It also comes with an EEG transceiver and decoding software, a medical testing software, and a clinical management software.
According to the regulator, the BCI system is strictly intended for patients aged 18-60 years with quadriplegia caused by high-level cervical spinal cord injuries (C2-C6). They must have been diagnosed for more than a year, have a stable condition at least six months after standardised treatment, and be unable to perform grasping movements, but with some remaining upper arm function.
The NMPA cited clinical trial results, which noted users reported significant improvement in hand grasping ability through brain-driven control.
The product was approved under China's "innovative medical device" pathway, a fast-track regulatory channel for breakthrough technologies.
THE LARGER CONTEXT
The approval places China among the first markets to formally clear implantable BCI systems for clinical use.
BCIs, alongside AI and quantum technology, were identified as a "future industry" in China's 15th Five-Year Plan, approved earlier this month. This means directing policy and financial support toward BCI, with focus areas including neurorehabilitation, advanced prosthetics, and human-machine communication.
"The NMPA has allocated resources to product review and approval, providing pre-approval services for innovative products, effectively accelerating the product launch process, and significantly enhancing the international competitiveness of China's high-end medical devices," the regulator said.
Also supporting China's BCI development, the Hong Kong Polytechnic University (PolyU) recently unveiled an "all-acoustics" BCI system that utilises transcranial ultrasound neuromodulation to target deep brain regions to alleviate symptoms of age‑related disorders, such as Parkinson's disease.
"Our BCI system can communicate with the brain to modulate its functions. With our PolyU-developed helmet-shaped gear, we can modulate brain cells by utilising ultrasound to achieve non‑invasive treatment for relieving Parkinsonian symptoms," explained PolyU biomedical engineering professor Sun Lei, who co-developed the BCI system.
