China Launches World's First Approved Implantable Brain-Computer Interface Device

Source: People's Daily

Original Title: The World's First Approved Implantable Brain-Computer Interface Device Born in China

New Form of Human-Computer Interaction Enters Clinical Use (In-Depth Observation)

Figure ②: Zhao Guoguang (right), President of Xuanwu Hospital, Capital Medical University, discusses the first GCP (Good Clinical Practice for Medical Device Clinical Trials) multicenter clinical trial implantation surgery plan for the "Beijing Brain One" intelligent brain-computer system with his team. Photo provided by Xuanwu Hospital, Capital Medical University.

Fig. ③: Visitors experience the Neuracle brain-computer interface for active and passive rehabilitation training of upper and lower limbs at the 2026 China Medical Equipment Exhibition. Photo by Xinhua News Agency reporter Huang Wei.

Data Source: China Academy of Information and Communications Technology, CCID Consulting, etc.

Not long ago, the National Medical Products Administration officially approved the first domestically produced implantable brain-computer interface product's medical device registration certificate, marking the world's first market launch of a brain-computer interface medical device. This cutting-edge technology, hailed as the "ultimate form of human-computer interaction," has entered the clinical application stage for the first time in the capacity of a medical device.

The "15th Five-Year Plan" outline lists brain-computer interface as one of the future industries for forward-looking deployment, promoting the application of brain-computer interface products in the diagnosis and treatment of brain diseases, motor rehabilitation therapy, health monitoring, and other fields. As brain-computer interface technology continues to mature in clinical applications, a new industrial track is gradually taking shape.

Technology moves from the laboratory to clinical application

As early as the 1970s, scientists began exploring the possibility of direct communication between the brain and external devices. "The basic principle of brain-computer interfaces is to establish an information channel between the brain and external devices that does not rely on peripheral nerves and muscles," introduced Professor Hong Bo from the School of Biomedical Engineering at Tsinghua University. By collecting and interpreting neural electrical signals generated during brain activity and converting them into commands, users can control external devices with their "thoughts."

The implantable brain-computer interface system for hand motor function compensation (NEO), recently approved, was jointly developed by Neuracle Medical Technology (Shanghai) Co., Ltd. and the School of Biomedical Engineering at Tsinghua University. "For patients with quadriplegia caused by cervical spinal cord injuries, who are unable to perform grasping motions with their fingers, we minimally invasively implant a coin-sized device beneath the dura mater. The system collects and deciphers the patient's EEG signals in real time, enabling them to control a pneumatic glove with their 'thoughts' to perform actions such as grasping, picking up objects, and drinking water," said Wang Yujing, Product Director at Neuracle.

However, the path from the laboratory to clinical application is not an easy one. The team members of Neuracle explained that for brain-computer interfaces to become a usable medical device, they must overcome multiple challenges: in terms of hardware, the electrodes implanted in the brain need to have both long-term biocompatibility and high-precision signal acquisition capabilities; in terms of software, neural decoding algorithms must be real-time, accurate, and stable; clinically, it is necessary to verify its long-term safety and functional effectiveness.

"Among all technical routes, implantable brain-computer interfaces are considered to have the highest technical difficulty," said Wang Yujing. Directly implanting electrodes into the cerebral cortex involves risk challenges in areas such as craniotomy surgery, biological tissue reactions caused by long-term implantation, wireless transmission, and power supply safety.

In the past, patients often had to wear a wired system with "braids" on their heads to achieve communication between the brain and the outside world. Pu Muming, an academician of the Chinese Academy of Sciences and the academic director of the Center of Excellence for Brain Science and Intelligence Technology, said that in recent years, brain-computer interfaces have been developing towards chip miniaturization, high-speed decoding algorithms, breakthroughs in precision electrode technology, and transitioning from laboratories to clinical applications. Previously, China has completed dozens of clinical surgeries. Trial data shows that the grasping function of the subjects has improved to varying degrees, and some patients have shown signs of neural remodeling, recovering additional neurological functions.

"Minimally invasive implantation of chips in the epidural space can stably acquire EEG signals without contacting brain tissue or damaging nerve cells. It can also precisely interpret patients' motor intentions to achieve actions such as grasping and drinking. This is the most crucial clinical breakthrough," said Professor Mao Ying, President of Huashan Hospital Affiliated with Fudan University.

What left a deep impression on Mao Ying happened in 2024. Xiao Dong, a clinical trial patient, after training, was able to use a brain-computer interface device to grasp a water cup and drink independently with the help of an air-filled glove through mental commands. "This was an action he had been unable to complete since his high spinal cord injury," Mao Ying recalled. Later, after a longer period of rehabilitation training, Xiao Dong could not only lift dumbbells with his thoughts but also personally wrote the neat words "thank you." "The clinical application of brain-computer interface technology has helped patients in real life, which deeply moved me," Mao Ying said.

In clinical applications, Mao Ying's team also found that, with the help of brain-computer interfaces and through a large amount of precise training, almost all participating patients' neural circuits had new developments, achieving more neurological function recovery. This makes Mao Ying full of confidence for the future: "We know this path is feasible, and we will walk it more firmly in the future."

Recently, Beijing Tiantan Hospital affiliated with Capital Medical University and Xuanwu Hospital of Capital Medical University conducted the implantation surgery of the "BeiNao No.1" intelligent brain-computer system. An electrode as thin as a cicada's wing, integrated with 128 signal acquisition channels, was precisely placed in the corresponding brain region controlling hand movement to help spinal cord injury patients improve motor function. "Through clinical practice, brain-computer interfaces have brought tangible improvements to patients with spinal cord injuries, stroke, and more," said Li Yuan, Business Development Director of Beijing Xinzhide Neurotechnology Co., Ltd.

The industrial chain around brain-computer interfaces is taking shape at an accelerated pace.

Brain-computer interface devices are complex system integrations in the fields of materials, chips, algorithms, rehabilitation, etc., promoting industrial development by "using key points to drive the whole."

"The approval of this whole-machine product will drive the development of upstream basic components and downstream applications, improving the industrial closed-loop of medical-engineering integration," said Li Wenyu, Director of the Intellectual Property and Innovation Development Center of the China Academy of Information and Communications Technology and Secretary-General of the Brain-Computer Interface Industry Alliance. He noted that China has basically established a brain-computer interface industry chain covering all upstream and downstream segments, but overall development is still in its early stages.

Specifically, core components such as electrodes and chips have initially achieved localization in production. The development of high-end chips and biocompatible packaging materials is accelerating. Implantable whole devices are currently undergoing clinical practice with a focus on medical applications. Meanwhile, non-invasive brain-computer interface systems are gradually expanding their application scenarios in areas such as consumer goods, education, and industrial production.

From research and development to application, the brain-computer interface industry chain is rapidly taking shape, thanks to the collaboration of various innovative entities. Hong Bo introduced that the recently approved product is the result of joint efforts by universities, enterprises, hospitals, and medical device testing institutions, which has effectively bridged the innovation chain of brain-computer interface technology.

In Shanghai, this pattern of "collaborative combat" is particularly evident. Since 2017, Shanghai has launched key projects in brain science and brain-computer interfaces. Universities and research institutes have participated in core technology breakthroughs such as flexible electrodes, related companies have carried out product development, and medical institutions have conducted clinical applications, driving the rapid growth of brain-computer interface enterprises. Not long ago, Stair Medical secured 500 million yuan in strategic financing from the market. Li Xue, founder of Stair Medical, stated that the future goal is to make implantation simpler.

"The transformation of brain-computer interfaces from scientific research to industry is a profound shift filled with challenges and opportunities." Li Yuan stated that during the research phase, it is necessary to explore the technical principles and feasibility; moving towards industrialization, however, means enabling the technology to truly serve a broad patient population, achieving large-scale inclusive application—this process requires multiple rounds of rigorous validation.

In July 2025, the Ministry of Industry and Information Technology and six other departments released the "Implementation Opinions on Promoting the Innovative Development of the Brain-Computer Interface Industry," which calls for strengthening fundamental software and hardware research, creating high-performance products, and promoting the application of technological achievements. Li Wenyu stated that Beijing, Shanghai, Shandong, and other regions have introduced supportive policies for the innovative development of brain-computer interfaces, forming a favorable industrial landscape.

An institution predicted that, by 2027, the market size of brain-computer interface in China will reach 5.58 billion yuan, with an average annual growth rate of 20%. The industry generally believes that the future brain-computer interface industry will enter a stage of steady growth, and medical rehabilitation will become the main field.Driving Force, and gradually extend to more application scenarios.

To Achieve Scale Application, a Few More "Hurdles" Remain

According to incomplete statistics, there are over 3.7 million existing patients with spinal cord injuries in China, with approximately 90,000 new cases added each year. More than 70% of these patients are under the age of 50 at the time of injury. Brain-computer interfaces demonstrate broad application prospects. However, brain-computer interfaces still face several practical challenges.

First, technology. Hong Bo said that some core components and materials of brain-computer interface devices still need to accelerate independent research and development; the performance of brain electricity decoding needs further improvement. Mao Ying gave an example that the current technology is difficult to use for the treatment of children and elderly patients, and in the future, it is necessary to further explore how to improve universality, expand the scope of adaptable symptoms, cover patients at different stages of injury, with different degrees of damage, and of different age groups. Its large-scale application still depends on the development of biomanufacturing, material science, artificial intelligence, and other technologies.

Li Yuan believes that brain-computer interfaces require interdisciplinary talents with knowledge in both life sciences and information sciences, but such cross-disciplinary talents are relatively scarce. At the same time, achieving higher throughput, smaller size, and lower energy consumption in brain-computer devices while ensuring performance also requires repeated testing and continuous improvement.

Moreover, the brain-computer interface industry is still in its early stages of development, with high costs associated with equipment R&D, surgical implantation, and post-operative rehabilitation. Tao Hu, founder and chief scientist of Neuracle, gave an example: it often takes more than 10 years for implantable brain-computer interfaces to progress from research and development to profitability, requiring the entry of more patient capital.

Ethical and regulatory issues cannot be ignored. As one of the latest medical technologies, brain-computer interface often requires higher-level clinical trials to prove its effectiveness. "There should be sufficient scientific evidence, and research and treatment should be carried out on the premise of ensuring no additional harm to patients," said Mao Ying. He added that demonstration applications should be conducted in large hospitals or national medical centers with adequate safeguards.

"As a medical device implanted in the human body for the long term, its safety, effectiveness, and risk controllability should be comprehensively considered. The clinical value of different technical approaches should be utilized on the premise of ensuring patient safety," said Hong Bo.

Despite the many challenges, the industrial prospects of brain-computer interfaces remain broad. "Overall, the market size of the brain-computer interface industry will enter a period of steady growth, with both the global and Chinese markets showing a rapid expansion in scale and continuous optimization in structure," Li Wenyu analyzed. With advantages such as policy support, a complete industrial chain, and rich application demands, China's brain-computer interface industry is expected to further develop. It is recommended to simultaneously improve safety governance measures such as ethical reviews and privacy protection for brain-computer interfaces.

Zhao Zhengtuo, a researcher at the Center for Excellence in Brain Science, outlined a clear path for technological development: In the short term, the reconstruction of motor and language functions will achieve large-scale applications; in the medium term, breakthroughs will be made in the restoration of artificial vision, hearing, and other sensory functions, as well as precise regulation of neuropsychiatric disorders; in the long term, it is expected to give rise to medical consumption and even general consumer scenarios, achieving a certain degree of functional enhancement. "In the future, humans will control external devices as if they were controlling their own limbs, achieving true human-machine integration," said Zhao Zhengtuo.

"With the support of national policies, as brain-computer interface technology matures, costs decrease, market awareness improves, and regulatory rules are perfected, brain-computer interfaces are expected to achieve larger-scale market applications in the next three to five years, bringing benefits to more people," said Li Yuan.