China Health Trip takes you through the latest medical breakthroughs in China, showcasing the possibilities of advanced healthcare. Read on for more insights.

The first brain-computer interface implantation and clinical trials

On November 6th 2024, Xiao Dong, paralyzed for four years, lay on the neurosurgery operating table at Huashan Hospital, affiliated with Fudan University, awaiting a groundbreaking treatment that sounds almost like science fiction—a brain-computer interface (BCI) device the size of a coin was about to be embedded outside his skull. This device would successfully capture neural signals from the sensorimotor areas of his brain. The implanted BCI system was co-developed by Boruikang Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Boruikang”) and the research team led by Professor Hong Bo from the Department of Biomedical Engineering at Tsinghua University. The system features a wireless, minimally invasive design that avoids damaging brain cells. Remarkably, the patient can be discharged within a week post-operation. On the same day, the neurosurgery team at Huashan Hospital successfully conducted this clinical implantation trial. The trial, approved by the hospital’s ethics committee, complies with the Good Clinical Practice (GCP) for Medical Device Clinical Trials and the Administrative Measures for Ethical Review of Science and Technology (Trial).

“Our BCI system utilizes a semi-invasive design,” explained Wang Yujing, Boruikang’s Product Director. “The device is incredibly small, about the size of a coin, and is implanted just above the skull, beneath the scalp. After the surgery, the scalp is re-covered, and once the hair grows back, the presence of the device is nearly undetectable.” 

According to reports from the International Brain-Computer Interface Conference, Xiao Dong’s postoperative recovery progressed well. He was discharged on November 15th and has since been actively undergoing rehabilitation training. He has already achieved the milestone of successfully drinking water using brain control. 

Hope and choices for paralyzed patients

The story of technology changing destiny seems to be happening, but have paralyzed patients found a “cure”? The answer is still on the way.

“A Simple Surgery”? 

Xiao Dong, who became paralyzed due to an accident four years ago, has been relentlessly searching for a “cure.” A year earlier, on October 24th, a 54-year-old patient named Lao Yang underwent the country’s first BCI implantation surgery at Xuanwu Hospital, Capital Medical University, preceding Neuralink’s first clinical implantation by three months. “When I saw Lao Yang lift a cup to drink water again, I couldn’t help but cry. For those of us with spinal cord injuries, this feels like a gift from heaven,” Xiao Dong recalled. Inspired by Lao Yang’s success, Xiao Dong resolved to participate in this BCI clinical trial. 

“Of course, I was nervous when I first heard about undergoing BCI surgery, especially since it was the first time this procedure was being done,” he admitted. “But if it allows me to regain basic self-care abilities—dressing and eating on my own—it would be a dream come true.” 

Xiao Dong’s surgery represents a bold attempt filled with hope and risk. Can embedding a BCI into a patient’s brain truly enable brain-controlled functions such as drinking water autonomously? Both doctors and patients are cautiously evaluating its potential benefits and risks. 

“Our R&D team has been working tirelessly to balance safety and efficacy, ensuring the highest standards,” Wang Yujing noted. “Our BCI device is exceptionally thin and small, making the surgical procedure relatively straightforward. Compared to traditional neural stimulator implantation, our surgery could indeed be described as a ‘simple’ procedure.” 

Brain-computer interface technology

Unlike traditional neural stimulators, this semi-invasive brain-computer interface technology relies not only on the implanted chip but also incorporates an external device. “We use a small magnetic suction coil that allows patients to attach it to the internal device under the scalp, similar to wireless charging for a smartphone,” explained Wang Yujing. “This external device provides power, transmits signals, and performs real-time algorithm updates. Additionally, we have developed pneumatic gloves that patients can control using brain signals to complete grasping and other movements, forming a closed-loop process.”

At the same time, regulatory support for brain-computer interface technology in China is steadily advancing. In August of this year, Boruikang’s minimally invasive brain-computer interface was included in the National Innovative Medical Device Special Review Program (“Green Channel”), providing a pathway for its formal clinical application. Wang Yujing disclosed, “Our implanted brain-computer interface system is likely to become the world’s first such system to receive a medical device registration certificate, which marks a significant milestone for us.”

“This is only the first step. In the future, we aim to make this system even smaller and less invasive, enabling more patients—and eventually everyone—to benefit from it,” she added.

Technological advancements and minimally invasive breakthroughs

The collaboration between Boruikang and Huashan Hospital has spanned many years. This implantation surgery marks the nation’s first case of using “somatosensory evoked potentials” combined with “real-time high-frequency signal analysis” for dual-modal precision functional localization of electrode implantation sites. The core of this technology lies in real-time collection and analysis of brainwave data, helping doctors precisely identify the hand sensory-motor functional areas of the patient and ensure accurate electrode placement.

“For the first time, we brought this system into today’s operating room,” Wang Yujing said with confidence in the technology during discussions about the clinical trial. “The greatest highlight of this system is that it can precisely locate functional areas and optimize electrode placement through a combination of the ‘gold standard’ of neuroelectrophysiology and real-time high-frequency brainwave signal analysis—all without waking the patient.”

In traditional functional localization methods, it is usually necessary to wake the patient from anesthesia during the surgery and have them cooperate with electrical stimulation assessments to evaluate brain area functions. “Our technology eliminates the need to wake the patient and has absolutely no side effects. Even when the patient cannot cooperate, we can still accurately determine the activity level of hand functional areas,” she explained.

As the technology continues to evolve, the team is developing higher-density and higher-throughput electrodes to cover a broader range of brainwave regions. “In the future, I hope our system will not only help patients complete basic movements like drinking water or walking but also assist with fine motor control, such as playing the piano or writing,” Wang added.

“Boruikang has been deeply engaged in the brain-computer interface field for many years. As a leading enterprise in this domain, we have advanced from non-invasive to invasive technologies on the technical front, and from brain science research to clinical diagnosis and rehabilitation on the product front,” said Xu Honglai, founder and chairman of Boruikang Technology. “Over the past two years, we have made significant breakthroughs in both sales and research and development, particularly in the clinical progress of minimally invasive brain-computer interfaces. We achieved a major milestone with human trials, going from ‘0 to 1,’ yielding excellent clinical results and passing the special review for innovative medical devices. This validates the ‘minimally invasive implantation’ approach as a safe and effective technological pathway.” 

Shanghai’s brain-computer interface industry ecosystem: accelerating the development of future industries

“Boruikang has just completed the signing of a Series D financing agreement, led jointly by Shanghai State-Owned Capital Investment’s Futeng Capital and the Leading Zone Fund under Pudong Venture Capital,” said Xu Honglai. “With subsequent support from the Shanghai Science and Technology Commission and municipal and district-level state-owned assets, our human trials will be fully launched. I believe the advantages of this technological pathway in terms of commercial prospects will gradually become apparent.”

In his view, “Shanghai not only provides us with abundant clinical application scenarios but also offers numerous opportunities for the transformation of research outcomes through its strong ecosystem of industry-academia-clinical collaboration.”

In recent years, Shanghai has actively promoted innovation in cutting-edge brain-computer interface (BCI) technologies to accelerate the cultivation of future industries. By leveraging market-oriented financing, support from major scientific projects such as the Science and Technology Innovation 2030 initiative, and other resources, innovative companies like BrainTiger Tech and Boruikang (Shanghai) have emerged, creating products in the invasive and semi-invasive BCI tracks.

“Shanghai’s atmosphere of innovation is incredibly robust,” said Wang Yujing. “It’s a young, vibrant place. For technology companies, Shanghai offers both high market potential and strong resource alignment. Almost all upstream and downstream resources in the BCI industry can be found here, from raw materials and chips to electrodes and external device manufacturing, with comprehensive solutions available.”

Reportedly, Shanghai continues to deepen research into frontier BCI technologies and cultivate future industries. It focuses on invasive and semi-invasive BCI tracks, advancing product development, building common technology R&D service platforms, promoting clinical trials and application demonstrations, improving product standards and testing systems, and fostering an industrial ecosystem. Additionally, it supports non-invasive BCI products in enhancing technological capabilities and expanding application scales. By 2027, the goal is to realize the clinical application of BCI products in China, significantly improving the quality of life for patients with paralysis, aphasia, and neurological diseases, while establishing an initial innovation ecosystem.

“The Shanghai Science and Technology Commission has been a crucial bridge in bringing our company to Shanghai,” Wang Yujing shared. Through long-term research and field visits, they keenly identified the future potential of BCI technology and ultimately decided to bring us to Shanghai, creating today’s collaborative opportunities.

Wang Yujing particularly emphasized that their collaboration with Huashan Hospital and other Shanghai medical institutions was also facilitated by the Commission. “This has been key to successfully partnering with these top-tier hospitals,” she noted.

“Through close cooperation with leading medical institutions, Boruikang has accelerated the validation and optimization of BCI technology in real clinical applications while promoting the rapid transition of experimental data and research results into clinical efficacy. This model not only shortens the time for technology to reach practical application but also lays a solid foundation for expanding the use of BCI in neurological rehabilitation and disease diagnosis and treatment in the future,” said Xu Honglai.

Furthermore, he pointed out that due to the current lack of mature chip solutions for neural signal acquisition, wireless powering, and communication in BCI systems, Boruikang plans to collaborate with Shanghai’s top semiconductor design universities and enterprises. “We aim to enhance system performance from the ground up, further strengthening the localization of critical technologies and laying a solid foundation for efficient and stable BCI systems,” he added.