On January 30, Elon Musk announced that his brain-computer interface (BCI) company, Neuralink, had completed the first human implantation of an invasive BCI device. On January 31, Professor Zhao Guoguang’s team from Xuanwu Hospital of Capital Medical University and Professor Hong Bo’s team from the School of Medicine at Tsinghua University announced the completion of the world’s first clinical implantation trial of NEO (Neural Electronic Opportunity), a wireless minimally invasive implanted BCI. Currently, China’s technological capabilities in the field of brain-computer interfaces are on par with those of Elon Musk, with the BCI implantation performed by Xuanwu Hospital and Tsinghua University being completed three months earlier than Musk’s.
Currently, the practical applications of brain-computer interfaces (BCIs) are primarily concentrated in the medical field, where they have played a significant role, particularly in the treatment of epilepsy. Meanwhile, advancements in computing power in recent years have provided more robust tools for BCI development. According to McKinsey’s estimates, the potential market size for global medical applications of BCIs is expected to reach $40 billion to $145 billion between 2030 and 2040. However, achieving “complete mind-controlled machine operation” or “consciousness immortality” still faces fundamental theoretical challenges, remaining far removed from the scenarios depicted in science fiction films. Elon Musk posted on social media that initial results following the brain-computer interface implantation indicate that “neural spike detection is promising.” He stated that Neuralink’s first brain-computer interface product, named “Telepathy,” enables users to control smartphones and computers, and thereby nearly all other devices, simply through thought after the device is implanted in the brain. The initial users of this product will be individuals who have lost limb function. “Imagine if Stephen Hawking could communicate via a brain-computer interface at a speed potentially faster than that of a typist or an auctioneer—that is our goal.” Elon Musk has almost annually leveraged social media platforms to promote his company’s initiatives. For instance, in 2020, he demonstrated the implantation of a chip into a living pig’s brain and the subsequent reception of its neural signals. In 2021 and 2022, he showcased monkeys playing games and typing via “telepathy.” During a 2020 speech, he stated that Neuralink Corp’s potential was nearly limitless, suggesting that future brain-computer interface technology could enable “mind control” and “digital immortality of consciousness.” To date, brain-computer interfaces are shining in the field of epilepsy treatment, truly benefiting patients in clinical applications. This technology, which gives epilepsy patients a new lease on life, is known as RNS (Responsive Neurostimulation). According to the “brain network” theory, epilepsy is a brain network disorder in which discharges originating from a localized brain network propagate throughout the entire brain network, causing neurological symptoms. An innovative study led by Zhao Guoguang’s team involves clinical trials of implantation surgery for a domestically produced brain–computer interface neural stimulation system. This approach entails implanting an artificial intelligence chip intracranially to continuously monitor electroencephalographic rhythms day and night. Upon predicting an impending epileptic seizure, the system initiates exogenous rhythmic interference to directly block seizure formation, thereby opening a lifeline for some patients with refractory epilepsy by addressing the root cause. Min Dong, Deputy Director of the Cloud Computing and Big Data Research Institute, China Academy of Information and Communications TechnologyIt was stated that, in addition to treating epilepsy, brain-computer interfaces (BCIs) also have clinical applications in the field of rehabilitation. “For example, the Disorder of Consciousness Ward of the Department of Neurosurgery at Beijing Tiantan Hospital, Capital Medical University, employs BCI technology for the assessment, diagnosis, and prognosis prediction of consciousness in patients with disorders of consciousness. By detecting and modulating neural activity, analyzing and decoding brain network activity characteristics, and combining central and peripheral nerve signal detection techniques, the system integrates multiple types of feature signals. This enables patients with relatively high levels of residual consciousness to control external devices through hybrid human-computer interaction, significantly improving their quality of life.” WuXi AppTec’s content team stated that, focusing on the Chinese market and assuming a unit price of RMB 50,000 per brain-computer interface (BCI) device (excluding services and other consumables), the potential market size for BCI in China’s serious medical sector exceeds RMB 100 billion. Refractory epilepsy and stroke rehabilitation represent the largest market segments and are currently the most clinically mature areas for exploration and application. At the policy level, brain-computer interfaces are receiving increasing attention. On January 29, the Ministry of Industry and Information Technology (MIIT) and six other departments jointly issued the “Implementation Opinions on Promoting the Innovative Development of Future Industries.” The document listed brain-computer interfaces (BCIs) as “iconic innovative products.” The opinions stated, “Breakthroughs should be achieved in key technologies and core components such as brain-computer integration, neuromorphic chips, and computational neural models of the brain; a batch of user-friendly and safe BCI products should be developed; and exploration of their applications in typical fields such as medical rehabilitation, autonomous driving, and virtual reality is encouraged.”“Brain-computer interface (BCI), as a cutting-edge interdisciplinary technology, has attracted significant attention in recent years. China’s 14th Five-Year Plan lists brain science and brain-inspired research as national strategic scientific and technological forces, vigorously promoting breakthroughs in frontier BCI technologies. The issuance of the ‘Implementation Opinions on Promoting the Innovative Development of Future Industries’ will undoubtedly play a significant role in advancing the development of BCI technology and industry, with far-reaching implications,” said Min Dong. In his view, policy-level support helps attract more research institutions and technology enterprises to invest in this field, accelerating the research and development of related technologies. This "focus" may lead to significant scientific discoveries and technological innovations, drive synergy across the industrial chain, and lay the foundation for the maturation of brain-computer interface (BCI) technology. The policy’s encouragement of applications in fields such as medical rehabilitation, autonomous driving, and virtual reality not only promotes the translation of products from the laboratory to the market but also accelerates the exploration of BCI technology across various industries, further expanding its application scope and social value. Meanwhile, such policy-driven momentum will enhance public awareness of this technology, while simultaneously drawing attention to associated ethical and safety concerns. Currently, brain-computer interface (BCI) products are categorized into invasive and non-invasive types based on their technological approaches. Invasive BCIs can acquire clearer electroencephalogram (EEG) signals but are constrained by high risks, technical complexity, and ethical considerations, requiring appropriate medical qualifications. In contrast, the development of non-invasive BCI products is relatively easier, potentially targeting a broader population in the future. Min Dong believes that, from a technical perspective, whether using invasive or non-invasive technologies, challenges such as the accuracy of signal perception, the speed of signal transmission, and the complexity of data processing urgently need to be overcome. “Currently, our understanding of the human brain remains relatively superficial, and research into brain mechanisms, such as neuronal mechanisms, still needs to go deeper.” In response to these challenges and pain points, in September 2023,CAICT’s Cloud Computing and Big Data Research Institute Leads the Establishment of the Brain-Computer Interface Research Working Group under the AI Medical Device Innovation Cooperation PlatformEarlier, the AI Medical Device Innovation Cooperation Platform was jointly initiated and established by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) and the China Academy of Information and Communications Technology (CAICT), among other entities, under the guidance of the NMPA, the Ministry of Industry and Information Technology, the National Health Commission, and the Ministry of Science and Technology. “Our Brain-Computer Interface (BCI) Working Group aims to effectively coordinate resources from relevant research institutions, clinical facilities, academic societies, and other stakeholders to foster scientific and industrial collaboration, thereby achieving resource sharing. We regularly conduct comprehensive surveys on the current status of BCI-related medical device technologies and industries to accurately identify bottlenecks, pain points, and challenges hindering technological and industrial development. In the near term, we will also carry out research on key issues of concern, including the performance evaluation of BCI system algorithms, testing methods for communication performance of BCI-based medical devices, and the protection of personal information of BCI users. These efforts are intended to support the research and development, training, testing, and application of novel BCI products,” said Min Dong. According to the Cloud Computing and Big Data Research Institute of the China Academy of Information and Communications Technology (CAICT),“White Paper on the Application of Brain-Computer Interface Technology in the Healthcare Sector (2023)”From 2013 to 2022, the number of brain-computer interface (BCI) patent applications in the medical field totaled 1,239. China had the highest number of published patents, with 602, surpassing other countries such as the United States (195) and South Korea (119). As of the first quarter of 2023, global financing for representative BCI companies had exceeded $10 billion. Min Dong stated that the primary application areas for brain-computer interface (BCI) technology include healthcare, entertainment, smart living, education, and the military. For instance, BCIs can enable the control of smart home devices—such as lighting, televisions, and climate control systems—through thought, thereby enhancing the comfort and quality of life for individuals with disabilities and the elderly. In the realms of gaming and virtual reality, BCIs can offer more immersive and intuitive interactive experiences. Undoubtedly, the medical field represents the most significant area of BCI application. While encouraging and promoting technological and industrial development, it is essential to give full consideration to issues such as safety, accuracy, reliability, and user privacy protection.
Reposted from The Beijing News
END
Intelligent Medical Device Laboratory
01
Laboratory Introduction
The NMPA Key Laboratory for Research and Evaluation of Intelligent Medical Devices, led by the China Academy of Information and Communications Technology, aims toConduct research and consulting, standard setting, inspection and testing, experimental verification, and platform establishment, with a focus on the research, development, and innovation of intelligent medical devices, enhancement of regulatory capabilities, and implementation of related achievements. Address bottlenecks and challenges in the industrial chain, and strive to produce a batch of new regulatory tools, methods, standards, and systems for innovative medical devices.Focus on promoting the translation and application of innovative achievements,Build internationally leading and domestically first-class intelligent medical device lifecycle service capabilities, and construct a new ecosystem for the intelligent medical device industry.
02
Organizational Structure
The laboratory comprises five major research centers: the Remote Medical Device Research Center, the Artificial Intelligence Medical Device Research Center, the Network and Data Security Research Center, the Basic Technology Research Center, and the Regulatory Science Research Center.