China clears world’s first commercial invasive brain-computer interface
The approval places China at the forefront of brain-computer interface adoption, with the device now covered by national health insurance for patients with spinal cord injuries.
China has granted regulatory approval for the NEO invasive brain-computer interface, developed by Neuracle Technology and Tsinghua University, marking the first time such a device has been cleared for commercial use globally beyond clinical trials. The coin-sized implant, which rests on the brain’s protective dura mater rather than penetrating the cortex, enables patients with spinal cord injuries to control external devices, including soft robotic gloves, to perform daily tasks.
The approval follows an expedited regulatory pathway supported by the Chinese government, distinguishing it from the slower, more rigorous processes typical of the US Food and Drug Administration. Consequently, the NEO device has been incorporated into China’s national health insurance system, with a unique code assigned to facilitate patient access. This move aligns with the country’s latest five-year plan, published on the same day as the approval, which lists brain-computer interfaces as one of six key industries for future technological competitiveness.
Clinical efficacy was demonstrated by patient Dong Hui, 39, who was paralyzed from the neck down following a car accident in 2019. After undergoing surgery in November 2024 and completing 11 months of rehabilitation, Dong successfully wrote his name and the date using the device. He reported that by the ninth day of training, he could grab objects without the robotic glove, a milestone he described as miraculous. The National Medical Products Administration states the device is suitable for patients aged 18 to 60 with quadriplegia resulting from spinal cord injuries who retain some residual arm function.
Neuracle Technology conducted 36 clinical trials for the NEO device, with 32 taking place in 2025. Experts note that the device’s design, featuring eight sensors placed on the brain’s outer membrane, presents lower risks of haemorrhage and glial scarring compared to competitors like Neuralink’s N1 chip, which directly penetrates the brain’s cortex. This less invasive profile, combined with strong state support, allowed for faster regulatory clearance.
The approval highlights diverging strategic visions between China and Western nations. While US efforts often focus on achieving state-of-the-art performance, China’s approach emphasises societal scale and accessibility. Despite geopolitical tensions, collaboration continues in the sector, with US company Axoft conducting trials in Shanghai. Other domestic devices, such as Beinao-1 by NeuCyber NeuroTech, are in the pipeline and could receive approval as early as 2028.
