China approves world’s first invasive brain-computer interface for clinical use
The device, developed by Neuracle Technology and Tsinghua University, marks a strategic shift in medical technology deployment as China accelerates its push for global leadership in the sector.
China has granted regulatory approval for the NEO invasive brain-computer interface (BCI), a development that marks the world’s first such device authorised for use beyond clinical trials. The decision follows a successful trial involving Dong Hui, a patient paralyzed from the neck down, who used the implant to write his name and other text. The approval is expected to accelerate China’s efforts to become a global leader in brain implant technology, aligning with the country’s latest five-year plan.
The NEO device, developed by Neuracle Technology and Tsinghua University, is a coin-sized implant designed to rest on the brain’s dura mater rather than penetrating the cortex. This design enables patients with spinal cord injuries to control external devices through brain signals. The approval was granted via an expedited regulatory pathway supported by the Chinese government, a process that contrasts with the typically slower and more rigorous procedures of the US Food and Drug Administration.
In a move to facilitate patient access, the NEO device has been incorporated into China’s national health insurance system, with a unique code assigned to streamline its availability. This approach highlights a diverging strategic vision between China and Western nations regarding medical technology. While Western efforts often focus on achieving state-of-the-art performance, China’s strategy emphasises societal scale and accessibility.
Despite ongoing geopolitical tensions, collaboration continues in the sector. US company Axoft is currently conducting trials in Shanghai, demonstrating that cross-border research persists even as export curbs on AI chips tighten. Other domestic devices, such as Beinao-1 by NeuCyber NeuroTech, are reportedly in the pipeline, indicating a growing domestic industry.
The approval distinguishes China’s strategic approach to medical innovation, prioritising rapid deployment and broad access. While the long-term efficacy and safety profile of the NEO implant for widespread commercial use remain to be fully established, the regulatory milestone signals a significant step in the global race for brain-computer interface technology.
