Sci-Tech

Shanghai Pudong: Unlocking the "Global First Certificate" of Brain Computer Interface - Accelerating the Cultivation of Biomedical "Tropical Rainforest"

2026-04-08   

Recently, the National Medical Products Administration announced the approval of Borui Kang Medical Technology (Shanghai) Co., Ltd.'s innovative product registration application for the "Implantable Brain Computer Interface Hand Movement Function Compensation System" (NEO), achieving the global launch of brain computer interface medical devices. A landmark "global first certificate" has been unveiled in Pudong New Area, Shanghai. Brain computer interface is one of the future industries that China will focus on during the 15th Five Year Plan period. In this field, Neuralink, founded by Musk, has attracted global attention. The significant breakthrough achieved by Borui Kang not only brings hope for rehabilitation to many patients at home and abroad, but also demonstrates China's accumulation and development in the field of brain computer interfaces. Including brain computer interfaces, Shanghai Pudong is continuously emerging "3F" innovative products that are globally first in class, first in China, and clinically first in human, accelerating the construction of a world-class biopharmaceutical industry cluster. Five years ago, a car accident caused a Henan young man named Xiao Dong to be paralyzed from a high position in the competition brain computer interface innovation "full track". In November 2024, Huashan Hospital affiliated with Fudan University implanted a device about the size of a coin into Xiao Dong's head - the approved Borui Kang implantable brain computer interface system. This is the first implantable brain computer interface surgery in Shanghai. One week after the surgery, Xiao Dong was discharged from the hospital for home rehabilitation. During training, the brain computer interface accurately decodes the collected EEG signals, first "understands" Xiao Dong's intentions, and then converts them into instructions to drive the airbag gloves. Soon, Xiao Dong will be able to control the airbag gloves to grab wooden blocks with his mind. Half a year later, he can raise his glass and drink water by himself. With the continuous development of rehabilitation training, Xiao Dong underwent a new change one year later. Without the help of brain computer interface devices, he assisted each other with both hands and wrote the words "thank you". This is a qualitative leap, which means that patients have achieved greater neurological recovery while using external devices to restore hand movement function. ”Mao Ying, the director of Huashan Hospital affiliated with Fudan University, said. The brain computer interface that benefits Xiao Dong is a cutting-edge technology that enables information exchange between the brain and external devices by collecting and analyzing electrical signals from the brain. In this field, there are multiple technological approaches based on the degree of contact between electrodes and brain tissue, including invasive, semi invasive, and non-invasive methods. There is a complex trade-off relationship between the degree of trauma, signal quality, and stable application of various routes, known as the "triangle problem". Li Wenyu, Secretary General of the Brain Computer Interface Industry Alliance, told reporters: "The market demand targeted by each technology route is not the same, and it is not an either or substitution relationship. It is expected to achieve mutual promotion and integrated development in the future." As a highland of the domestic biopharmaceutical industry, Shanghai Pudong has gathered nearly 10 brain computer interface and related neuroscience enterprises, fully covering mainstream technology routes. Among them, the semi invasive route achieved a historic breakthrough first - Borui Kang's approved product NEO belongs to this category. At the same time, the invasive route is also accelerating its sprint. Located in Waigaoqiao, Pudong, Ladder Medical has completed its first flexible electrode implantation surgery in March 2025, and its clinical progress is currently at the forefront of the world. In the non-invasive field that the public is more familiar with, Pudong enterprises are using AI enabled technology to land and accelerate their entry into the daily consumer end. The Yansi Brain, located in Zhangjiang Science City, Pudong, has constructed a multimodal brain computer model with a parameter count of 5 billion, significantly improving its decoding ability for complex neural activities such as language and emotions. At present, non-invasive technology has been explored in scenarios such as sleep disorder intervention and attention regulation. Exploring the brain, rehabilitating the brain, and enhancing the brain "- these three exploration directions are particularly prominent in Borui Kang's office located in Zhangjiang Science City. The application prospects of brain computer interfaces are not only to help paraplegic patients, but also to enable direct dialogue between carbon based brains and silicon-based chips. In the broader field of neural function reconstruction, Pudong has also made comprehensive breakthroughs in multiple areas, such as accelerating the domestic replacement of deep brain electrical stimulation (commonly known as "brain pacemaker") with neuroscience, and related products have entered the clinical trial stage. In the field of auditory reconstruction, only five companies worldwide have semi implantable products approved for listing, including Lisheng Te in Pudong New Area. On the track of sports reconstruction, Meisheng Medical's Brain Spinal Interface (BSI) technology is also in the stage of clinical trials (IIT) initiated by researchers and has now entered the "breakthrough therapy" channel of the US FDA. The Action Plan for Cultivating the Future Industry of Brain Computer Interface in Shanghai (2025-2030) proposes that by 2030, Shanghai will achieve high-quality brain control, fully implement clinical applications of brain computer interface products, and create a global innovation highland for brain computer interface products. In the field of brain computer interface, Pudong New Area is not relying on a single enterprise or technology to make a 'single breakthrough', but a 'comprehensive attack' with multiple technology routes parallel and multiple application scenarios covering, to help Shanghai build a global innovation highland for brain computer interface products, "said Lin Jianfei, Director of the Biomedical Department of Pudong New Area Science and Technology Commission. On March 13, 2026, Borui Kang's implantable brain computer interface products were approved by the National Medical Products Administration for global launch and marketing, building a tropical rainforest style innovation ecosystem; On March 23rd, the Shanghai medical insurance department included this product in the local medical insurance consumables catalog - it only took 11 days from approval to clinical implementation, demonstrating the importance of innovative ecology in exploring cutting-edge technologies and cultivating future industries. From a technical perspective, brain computer interfaces span across multiple disciplines such as neuroscience, clinical medicine, materials science, microelectronics, etc. There is often a gap between "technological innovation" and "commercial implementation". Ling Gang, Deputy Director of the Science and Technology Commission of Pudong New Area, stated that Pudong is building a tropical rainforest style innovation ecosystem led by institutional guidance, innovative sources, industry collaboration, platform empowerment, and clinical and evaluation support, to help brain computer interface enterprises bridge the innovation gap. The source of this rainforest ecosystem, 'living water', comes from the innovative momentum continuously released by top research institutions. As an important pivot of the national "One Body, Two Wings" neuroscience program, the Institute of Brain like Intelligence Science and Technology at Fudan University Zhangjiang Campus is one of the first institutions in China to layout neuroscience research. The spillover effect of technology and talent is obvious, and five enterprises have been incubated. ShanghaiTech University has significant advantages in areas such as brain imaging algorithms and brain function decoding. It is reported that ShanghaiTech University is collaborating with Lingang Laboratory to further support technological innovation. To make the seedlings of scientific and technological innovation grow into towering trees, it is inseparable from the support of professional services. Establishing industry norms and standards is crucial. The Shanghai Medical Device Inspection and Research Institute, located in Pudong New Area, has established the most advanced and professional brain computer interface testing service platform in China. It has also taken the lead in formulating China's first brain computer interface medical device industry standard, which will be officially implemented on January 1, 2026, and will set clear boundaries for this future industry. Yu Hongyi, President of Shanghai Medical Device Inspection and Research Institute, told reporters that in the field of brain computer interfaces, the institute is synchronously promoting 6 national standards and plans to complete and publish more than 30 related national standards by the end of 2028. The foreign version of the standard is also under preparation and will be launched simultaneously after the official establishment of the national standard system, aiming to promote Chinese standards to the world. The flourishing of the industrial rainforest relies more on the fertile soil for innovation. Brain computer interface technology has distinct interdisciplinary characteristics, and the three leading industries of integrated circuits, biomedicine, and artificial intelligence are the core support for its development. As the core carrier area of Shanghai International Science and Technology Innovation Center, Pudong has continuously cultivated new quality productivity in recent years, forming a modern industrial system led by the three leading industries, advanced manufacturing as the backbone, and modern service industry as the support. By 2025, the scale of the three leading industries of integrated circuits, biomedicine, and artificial intelligence in Pudong New Area is expected to exceed 900 billion yuan, accounting for over 45% of the total in Shanghai, providing fertile ground for the development of brain computer interface technology. All the branches and leaves in the industrial rainforest must stretch towards the vast sky of the market. Currently, Pudong New Area is establishing a research base for brain computer interface applications, accelerating the process of "technology research and development clinical validation product optimization". Hu Dan, the director of Shanghai Seventh People's Hospital located in Waigaoqiao, Pudong, told reporters that relying on the core advantages of the hospital's rehabilitation specialty, the hospital is carrying out deep cooperation with brain computer interface enterprises in Pudong New Area, actively participating in the development of exclusive rehabilitation plans for brain computer interfaces and the construction of clinical application bases. Mi Yihua, the head of Meisheng Medical, said that the company specializes in Brain Spinal Interface (BSI) technology, which has a huge clinical demand both domestically and internationally. Relying on the free trade zone, enterprise research and development can enjoy policy dividends such as cross-border medical care and immigration convenience. The flourishing development of brain computer interfaces in forging world-class biopharmaceutical industry clusters is a microcosm of Pudong forging world-class biopharmaceutical industry clusters. According to data from the Pudong Science and Technology Commission, as one of the regions with the most complete biopharmaceutical industry chain, the best ecology, the most concentrated talent, the most active innovation, and the most efficient research and development in China, Pudong New Area has gathered more than 4000 upstream and downstream biopharmaceutical enterprises. By 2025, the industrial scale will reach 449.4 billion yuan, accounting for 43% of the entire city of Shanghai. Thick accumulation leads to thin hair. The systematic layout of Pudong New Area over the years is being transformed into a continuous stream of innovative achievements. Statistics show that Pudong New Area has approved a total of 31 first-class innovative drugs, ranking among the top in the country in terms of overall quantity. By 2025, 8 Class I innovative drugs and 6 Class III innovative medical devices will be approved for market launch. Since the beginning of this year, one Class I innovative drug and seven Class III innovative medical devices have been registered and launched. The internationalization pace of Pudong's biopharmaceutical industry has also significantly accelerated. By 2025, Pudong New Area will have a total of 42 external authorization and business cooperation transactions, with a total transaction volume of 25.5 billion US dollars, deeply embedded in the global biopharmaceutical innovation research and commercialization network. Leading technological innovation with institutional innovation, and solving industry pain points with precise services. ”The relevant person in charge of the Pudong New Area government expressed the "mindset" of developing the biopharmaceutical industry in Pudong. From piloting the system of drug marketing authorization holders, to promoting the facilitation of customs clearance for pharmaceutical research and development items on the "white list", to the current promotion of commercial medical supplementary insurance reform and research on import and production management system, Pudong has always been guided by enterprise demand to promote institutional innovation. A series of policy measures ultimately translate into tangible innovation efficiency: developing an innovative drug in Pudong only takes an average of 76 months and requires an investment of 620 million yuan, significantly lower than the cost of over 1 billion US dollars in developed countries. Pudong is building a world-class biopharmaceutical industry cluster, nurturing cutting-edge exploration and technological innovation. In the laboratory of staircase medicine, the world's smallest and most flexible neural electrodes are still being iterated. The invasive brain computer interface system developed by the team has entered the "green channel" for innovative medical device evaluation by the National Medical Products Administration. The future goal is to make implantation as simple as' nailing ears, '"said Li Xue, founder of Ladder Medical. In just five years since its establishment in Pudong, the company has maintained a high growth rate and continued to climb in development speed. The world-class biopharmaceutical industry cluster continues to release a powerful 'magnetic field effect'. Multinational pharmaceutical giant AstraZeneca recently announced the construction of a cell therapy innovation center in Zhangjiang Science City, Pudong. This full chain innovation platform will become a key hub of AstraZeneca's global cell therapy map, and also marks China's innovative position in the field of next-generation cell therapy

Edit:He Chuanning Responsible editor:Su Suiyue

Source:Xinhua

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