Shanghai Secures Global First Approval for Invasive Brain-Computer Interface Medical Device: What Worked?

Xinhua Finance, Shanghai, March 14th, by reporter Gu Qingzhu — As one of the first cities to strategically develop the brain-computer interface industry, Shanghai has achieved a significant breakthrough. On the 13th, the National Medical Products Administration announced the approval of Neuracle Technology (Shanghai) Co., Ltd.'s "Implantable Brain-Computer Interface System for Hand Motor Function Compensation" as an innovative product registration application. This marks the entry of the world’s first invasive brain-computer interface medical device into the clinical application stage.

Breakthrough: From "Silence" to "Restart," Illuminating NeurorehabilitationNew Hope

Brain-computer interface is not an entirely new concept; as early as the 1970s, the scientific community had already begun exploring the possibility of direct communication between the brain and external devices. However, it was not until recent years that the convergence of advancements in multiple technological fields — miniaturization of chips, high-speed decoding algorithms, precision electrode technology, and breakthroughs in artificial intelligence — has finally ushered in a period of rapid development for brain-computer interfaces, bringing new hope to the lives of "silent patients." These individuals are the "abandoned cases," who have been paralyzed due to stroke or trauma and have tried rehabilitation for many years without success.

Wu Zehan, the director of the Frontier Laboratory of Neurosurgery at Huashan Hospital Affiliated with Fudan University, once told Xinhua Finance the story of a patient named Xiao Dong. This was a patient who had been paralyzed for four years due to a high cervical spinal cord injury and performed a simple grasping motion with the help of an air-filled glove. "A very simple grasping action, but completed with the assistance of an implanted brain-computer interface device. Through 4 to 8 hours of training every day, we attempted to rebuild the neural pathways between the brain and the hand," Wu Zehan said. The most critical breakthrough occurred one time “after the device was turned off,” when Xiao Dong independently completed the action of “raising a cup” without wearing the brain-computer interface device. "It was an unforeseen moment for everyone, but it showed that the ‘pathway’ was established," Wu Zehan said.

The "Global Status Report on Neurology" released by the World Health Organization points out that neurological disorders currently affect more than 3 billion people worldwide, accounting for over 40% of the total population. In response, Professor Gao Xiaorong from Tsinghua University's School of Medicine stated that a 50-year (1975 to 2025) tracking of academic hot terms in the field of neuroscience shows that, thanks to the "spotlight effect" of brain-computer interface technology, "electroencephalography" (EEG), one of the core signal sources for brain-computer interfaces, has risen to become the second most researched topic in the field as of 2025, second only to "Alzheimer's disease," which has long topped the list. More importantly, the "hot term acceleration" of "electroencephalography" (1.7%) has significantly surpassed that of "Alzheimer's disease" (1.0%). Based on this, he predicts that in the next decade, "electroencephalography" is expected to surpass research related to "degenerative diseases" and become the top keyword in neuroscience — all of which marks that brain-computer interface technology is rapidly advancing toward the core stage of science and industry.

China places high strategic importance on brain-computer interface (BCI) technology. In July 2025, the Ministry of Industry and Information Technology and six other national departments released the "Implementation Opinions on Promoting Innovation and Development in the Brain-Computer Interface Industry" (hereinafter referred to as the "Implementation Opinions"). Brain-computer interfaces have been explicitly identified as a new track for future industries, with a systematic roadmap for industrial development outlined in stages: "By 2027, breakthroughs will be achieved in key BCI technologies, establishing an advanced technological, industrial, and standards system. The performance of electrodes, chips, and complete machines will reach international advanced levels, with BCI products being rapidly applied in industrial manufacturing, healthcare, and consumer living. The scale of the industry will continue to grow, creating 2 to 3 industrial development clusters, and pioneering a range of new scenarios, models, and business formats. By 2030, innovation capabilities in the BCI industry will significantly improve, forming a secure and reliable industrial system, nurturing 2 to 3 globally influential leading enterprises and a group of specialized, refined, distinctive, and innovative small and medium-sized enterprises, building an internationally competitive industrial ecosystem, and advancing overall strength to the forefront of the world."

Neuracle's technological breakthrough is a vivid example of the efficient implementation of this national strategy in China, making the vision of "awakening dormant nerves with Chinese technology" gradually become a reality.

Boundaries Still Exist: The "Precise Application" and "Practical Limitations" of Brain-Computer Interfaces

Reportedly, the product approved this time for Neuracle consists of a brain-computer interface implant, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic glove device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grip function compensation through the pneumatic glove device. It should be noted that patients need to meet the following conditions: aged 18 to 60, C2-C6 cervical spinal cord injury graded A-C level of quadriplegia, diagnosed for more than one year and with stable condition for at least six months after standardized treatment, unable to complete hand grip, with partial upper arm function remaining. This product adopts epidural minimally invasive implantation and wireless power supply communication technology. Clinical trial results show that subjects significantly improved their hand grip ability through this product, thereby enhancing the quality of life for patients.

Why is there such a strict limitation on the scope of application?

"While rejoicing at the good news, it is also necessary to calmly recognize that the launch of a brain-computer interface product only helps address one type of problem with a narrow range of indications. However, patients' needs are diverse," said Wu Zehan. He admitted that for a considerable period of time, breakthroughs in brain-computer interface technology will most likely benefit only those spinal cord injury paraplegic patients with stable vital signs, while the number of patients suffering from aphasia, ALS, and hemiplegia caused by stroke is ten times higher. "For the entire patient population, the number of beneficiaries remains relatively limited. Therefore, the public should maintain a rationally optimistic attitude towards technological development, avoiding excessively high expectations that could lead to 'secondary harm' caused by dashed hopes."

Gao Zhijun, Executive General Manager of Sinan Brain-Computer Intelligent Super Incubator, told Xinhua Finance that the core challenge in tackling neurological disorders lies in the difficulty of identifying targets, as the pathogenic mechanisms of diseases such as Alzheimer's, depression, and autism remain unknown. "Global pharmaceutical giants like Eli Lilly have experienced failures in three Phase III clinical trials for Alzheimer’s due to efficacy not meeting endpoints," he said. He noted that while brain-computer interface technology is highly anticipated, given the current lack of clear targets, it remains in a stage of technical exploration and concept validation akin to "a blind man feeling an elephant" when addressing many diseases. Therefore, the industry still has a long way to go in its development.

"Upstairs and Downstairs Are Upstream and Downstream": Shanghai Builds a "Tropical Rainforest" for Brain-Computer Interface Industry

In the view of Gao Xiaorong, brain-computer interface, as a typical interdisciplinary field, its development hinges on gathering cross-disciplinary technical talents and seeking the "greatest common divisor" of multi-disciplinary integration. Meanwhile, Shanghai, supported by the three leading industries of integrated circuits, biomedicine, and artificial intelligence, continues to strengthen its function as a source of scientific and technological innovation, with the scale of related industries surpassing 2 trillion yuan by 2025.

Building on this solid foundation, Shanghai has made intensive arrangements in the brain-computer interface field: In January 2025, the "Shanghai Brain-Computer Interface Future Industry Cultivation Action Plan (2025-2030)" was introduced; in July 2025, in Shanghai's New Hongqiao.International MedicineThe center has established "Brain Intelligence World" (hereinafter referred to as the "Agglomeration Area"), the first brain-computer interface future industry agglomeration area in China, focusing on building an agglomeration effect of "technological breakthrough - industrial transformation - scenario implementation" to accelerate the creation of an industrial "nuclear explosion point."

Today, the cluster area has successfully established two key laboratories: Huashan Hospital's Shanghai Key Laboratory of Brain-Computer Interface Clinical Trials and Transformation and the Shanghai Key Laboratory of Brain Function Reconstruction and Nerve Regeneration. Additionally, it includes Huashan Hospital Hongqiao Branch (National Center for Neurological Diseases) and Shanghai's first specialized carrier for brain-computer interface — Sinan Brain-Computer Intelligence Super Incubator (hereinafter referred to as "Sinan Incubator").

"Upstairs are scientists researching electrode materials, downstairs are doctors working on clinical transformation, and next door are engineers producing chips, along with a brain-computer interface concept verification platform — 'upstairs and downstairs form the upstream and downstream' is exactly the R&D ecosystem built by Sinan Incubator. Nearby are top domestic neurosurgical medical institutions such as Huashan Hospital, which performs about 20,000 neurosurgical operations each year." Gao Zhijun stated that the implementation of "serious medicine" technology in the field of brain-computer interfaces requires close integration between medicine and engineering, as well as support from mature and abundant clinical resources. The resource layout of the agglomeration area precisely meets this core requirement, laying a solid foundation for Shanghai to develop its brain-computer interface industry.

The value of the cluster area has broken through the boundaries of local resource integration. Relying on the core regional linkage advantages of the Hongqiao International Open Hub, the cluster is building a cross-regional collaborative network for brain-computer interface in the Yangtze River Delta, steadily moving towards becoming a national-level industrial development community for brain-computer interface, highlighting Shanghai's core leading role in the Yangtze River Delta's scientific and technological innovation collaboration. Lai Haofeng, Deputy General Manager of Lingang Science Investment Company and General Manager of Lingang Sinan Life Technology Super Incubator, believes that the cluster has formed a cross-regional linkage pattern: linking northward with Suzhou to achieve complementarity in the industrial and supply chains; integrating eastward with Zhangjiang’s excellent resources in testing, inspection, evaluation, and approval; leveraging Hangzhou’s advantages in medical product and digital technology integration to the west; at the same time, it can also link up with chip R&D resources in the new Lingang area.

Currently, the industrial cluster effect of the gathering area has initially emerged, attracting more than 10 high-quality enterprises in the industry such as Neuracle, Ladder Medical, and Brain Tiger Technology. Their business scopes cover several core fields of brain-computer interface, including wireless neural signal acquisition, vision restoration for the blind, and low-intensity focused transcranial ultrasound. Represented by the approval and market entry of Neuracle’s products, innovative achievements in brain-computer interfaces "Made in Shanghai" are rapidly growing from this "tropical rainforest," reaching across China and moving toward the world.

Editor: Lin Zhenghong