New Frontier of Human-Machine Interaction Enters Clinical Practice: Deep Observations on the Commercialization of Implantable Brain-Computer Interfaces
neuracle
Developer of Rehabilitation Assistance Systems
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Fig. 1: A patient undergoing brain-computer interface rehabilitation training at Beijing Jishuitan Hospital Guizhou. |
Not long ago, the National Medical Products Administration officially approved the first domestically-produced implantable brain-computer interface product's medical device registration certificate, achieving 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 Lab to Clinical Applications
As early as the 1970s, scientists began exploring the possibility of direct communication between the brain and external devices. "The basic principle of a brain-computer interface 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 Tsinghua University's School of Biomedical Engineering. By collecting and interpreting neural electrical signals produced 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), which has been recently approved, was jointly developed by Neuracle Technology (Shanghai) Co., Ltd. and the School of Biomedical Engineering at Tsinghua University. "For patients with quadriplegia caused by cervical spinal cord injury, 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 electroencephalogram 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 the long-term safety and functional effectiveness of its use.
"All technical routes considered, implantable brain-computer interfaces are regarded as the most technically challenging," said Wang Yuqing. Directly implanting electrodes into the cerebral cortex involves risks and challenges related to 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 moving from laboratories to clinical applications. Previously, dozens of clinical surgeries have been completed in China. Experimental data shows that the grasping function of the subjects has improved to varying degrees, and some patients have shown signs of neural plasticity, recovering additional neural functions.
"Implanting a chip minimally invasively in the epidural space, stably acquiring EEG signals without contacting brain tissue or damaging nerve cells, and precisely interpreting the patient's motor intentions to achieve actions such as grasping and drinking, 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 occurred 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 perform 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 neatly formed words "thank you." "The clinical application of brain-computer interface technology has genuinely 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 patients participating in the trial showed new developments in their neural circuits, achieving greater recovery of neurological functions. This gives Mao Ying great confidence for the future: "We know this path is viable, and we will move forward with even more confidence."
Recently, Beijing Tiantan Hospital, Capital Medical University, and Xuanwu Hospital, Capital Medical University, carried out 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 area controlling hand movements 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 interface 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 at 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 its overall development is still in the early stage.
Specifically, core components such as electrodes and chips have initially achieved production in China. The development of high-end chips and biocompatible packaging materials is accelerating. Implantable whole-machine products are currently conducting clinical practices with medical scenarios as the core. Meanwhile, non-invasive brain-computer interface systems are gradually expanding their application scenarios in consumer, education, and industrial production fields.
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 the joint efforts of universities, enterprises, hospitals, and medical device testing institutions, effectively bridging 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 the core technology breakthroughs such as flexible electrodes, relevant enterprises have carried out product development, medical institutions have conducted clinical applications, driving the rapid growth of brain-computer interface companies. Not long ago, StairMed obtained 500 million yuan in strategic financing from the market. Li Xue, founder of StairMed, stated that the future goal is to make implantation simpler.
"The transition of brain-computer interface from scientific research to industry is a profound shift filled with challenges and opportunities." Li Yuan stated that the research phase involves exploring technical principles and feasibility, while moving towards industrial application means enabling the technology to truly serve a large number of patients and achieve large-scale inclusive use, a process that requires multiple rounds of rigorous verification.
In July 2025, the Ministry of Industry and Information Technology and six other departments issued the "Implementation Opinions on Promoting the Innovative Development of the Brain-Computer Interface Industry," which calls for strengthening fundamental software and hardware research, developing high-performance products, and promoting the application of technological achievements. Li Wenyu stated that many regions, including Beijing, Shanghai, and Shandong, 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 driving force, gradually extending to more application scenarios.
To Achieve Scale Application, a Few More "Hurdles" Need to Be Overcome
According to incomplete statistics, there are over 3.7 million existing patients with spinal cord injuries in China, with about 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 many practical challenges.
First is the technology. Hongbo stated that some core components and materials of current brain-computer interface devices still require accelerated independent research and development; the performance of brain signal decoding needs further improvement. Mao Ying gave examples, stating that the current technology is difficult to apply in the treatment of children and elderly patients, and future exploration should focus on how to enhance universality, expand the range of treatable conditions, and cover patients at different stages and degrees of injury as well as different age groups. Its large-scale application still depends on advancements in 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 an implantable brain-computer interface to progress from development to profitability, requiring more patient capital to enter the field.
Ethical and regulatory issues cannot be overlooked. As one of the latest medical technologies, brain-computer interface often requires higher-level clinical trials to prove its efficacy. "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 emphasized that demonstration applications should be conducted in large hospitals or national medical centers with adequate safeguards.
"As a medical device that is implanted in the human body for the long term, its safety, effectiveness, and controllability of risks should be comprehensively considered. The clinical value of different technical approaches should be utilized under the premise of ensuring patient safety," said Hong Bo.
Despite the numerous challenges, the industrial prospects of brain-computer interfaces (BCIs) remain broad. "Overall, the market size of the BCI industry will enter a period of steady growth, with both the global and Chinese markets showing rapid expansion in scale and continuous optimization in structure," analyzed Li Wenyu. He pointed out that China, with advantages such as policy support, a complete industrial chain, and abundant application needs, is expected to further develop its BCI industry. It was suggested to simultaneously improve safety governance measures like ethical reviews and privacy protection for BCIs.
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 restoring sensory functions such as artificial vision and hearing, 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 become more complete, brain-computer interfaces are expected to achieve larger-scale market applications in the next 3 to 5 years, bringing benefits to more people," said Li Yuan.
People's Daily (April 14, 2026, Page 18)