First Invasive Brain-Computer Interface Medical Device Approved, Industry Officially Enters New Phase of Clinical Commercialization

21st Century Business Herald Reporter Yan Shuo

Brain-computer interface technology has officially achieved a critical leap from laboratory research to clinical application.

According to official information from the National Medical Products Administration, recently, the NMPA approved the registration application for an innovative product by Borui Kang Medical Technology (Shanghai) Co., Ltd. (“Borui Kang”)—an implantable brain-computer interface hand movement compensation system. This marks the world’s first launch of a brain-computer interface medical device, signifying that the world’s first invasive brain-computer interface medical device has entered the clinical application stage.

Industry experts believe that the approval and listing of this product is a significant advancement in the field of brain-computer interface medical applications. It provides new treatment options for patients with spinal cord injuries and paralysis, and also indicates that China is leading globally in the clinical translation of invasive brain-computer interface medical devices.

Following this news, the concept stocks related to brain-computer interfaces on Tonghuashun surged sharply during trading, then pulled back, with multiple stocks rising simultaneously. As of the close on March 13, Yingkang Life increased by over 12%, Beiyi Kang by over 7%, and Chuangxin Medical by over 6%.

A brain-computer interface is an interaction technology that establishes a direct information pathway between the human brain and external electronic devices. It is currently widely used in healthcare. Based on the implantation method, brain-computer interfaces are mainly divided into invasive, non-invasive, and semi-invasive types.

In recent years, China has seen a flurry of policies related to brain-computer interfaces. By 2025, the National Healthcare Security Administration issued the “Guidelines for the Establishment of Medical Service Price Items for Nervous System Diseases (Trial),” which separately listed prices for brain-computer interface-related medical services; the “14th Five-Year Plan” explicitly included brain-computer interfaces as one of six future industries; and this year, brain-computer interfaces were also included for the first time in the government work report.

Guosheng Securities analysts pointed out that these developments indicate that the field of brain-computer interfaces has moved from frontier technological exploration to a support framework within national industrial policies. For the pharmaceutical and medical technology sectors, including brain-computer interfaces as a future industry helps increase market attention to subfields such as neural regulation, rehabilitation robots, implantable medical devices, and interdisciplinary applications in brain science.

Realization of Product Application

Borui Kang was founded in 2011, with a core team from Tsinghua University’s Neural Engineering Laboratory. The company mainly engages in the research, development, production, sales, and technical services of brain-machine interface systems, providing solutions for neuroscience innovation research and clinical diagnosis, treatment, and rehabilitation of neurological diseases.

The approved product includes an implantable brain-computer interface, an implantable electroencephalogram (EEG) electrode set, EEG signal transmitters and receivers, pneumatic gloves, disposable surgical kits, 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 restoring hand grasp functions through pneumatic gloves.

Patients must meet the following conditions: aged 18 to 60, with C2–C6 cervical spinal cord injury graded A–C, diagnosed more than one year ago, with stable condition for at least six months after standardized treatment, unable to grasp with their hands, but with some remaining upper arm function. The device uses minimally invasive epidural implantation and wireless energy communication technology. Clinical trials show that subjects experienced significant improvements in hand grasping ability, thereby enhancing their quality of life.

Currently, the charging pathways for rapid clinical application of brain-computer interfaces are well established, and medical billing standards for brain-computer interface treatments are in place across multiple regions.

In March 2025, the National Healthcare Security Administration separately listed prices for brain-computer interface medical services, including “Invasive Brain-Computer Interface Implantation Fee,” “Invasive Brain-Computer Interface Removal Fee,” and “Non-invasive Brain-Computer Interface Adaptation Fee.” Local healthcare authorities have quickly followed suit, with provinces such as Hubei, Zhejiang, and Jiangsu announcing related service prices.

Jin Chunlin, director of the Shanghai Health and Wellness Development Research Center, previously told 21st Century Business Herald that these three items nearly cover the two main pathways most likely to be scaled up for clinical translation, greatly promoting the development of brain-computer interfaces. In fact, many new technologies struggle to be applied mainly due to the lack of unified service pricing.

In November 2025, China’s first government-guided price surgery for invasive brain-computer interface was performed at Tongji Hospital in Wuhan, with an implantation fee of 6,552 yuan (excluding device costs), covered by research funding, marking the formal entry of clinical billing into a standardized phase.

Notably, in January 2026, the Ministry of Industry and Information Technology and seven other departments jointly issued the “Implementation Opinions on the Special Action of ‘Artificial Intelligence + Manufacturing’,” explicitly calling for accelerating the industrialization and commercialization of brain-computer interfaces. The pace of industry commercialization is further speeding up.

However, it should be noted that there are still many bottlenecks to overcome before brain-computer interfaces can be widely implemented. “First, in data collection and interpretation, non-invasive brain-computer interface signals are relatively weak, while invasive ones are clearer, but the core challenge lies in biocompatibility. The brain reacts to foreign objects with rejection, so material requirements are high. Second, invasive brain-computer interfaces also need to address power consumption issues, considering battery capacity,” Jin Chunlin said. Additionally, cost considerations are crucial—small-scale experiments may not focus much on costs, but large-scale promotion requires low-cost solutions. Safety, legal regulations, and ethical issues also need to be addressed.

Policy and Industry Resonance

On March 10, nine departments including the Jiangsu Provincial Department of Industry and Information Technology issued the “Jiangsu Province Brain-Computer Interface Industry Innovation and Development Action Plan,” proposing to establish at least two provincial-level brain-computer interface industrial clusters by 2027; by 2030, to develop 2–3 influential leading enterprises domestically and internationally, recognize no fewer than 30 brain-computer interface “top three” and “new” products, and cultivate at least 30 typical applications of “brain-computer interface + consumer.”

Besides Jiangsu, Beijing, Shanghai, Sichuan, and other regions have successively released industry cultivation plans related to brain-computer interfaces. Since last year, multiple regions including Beijing, Wuhan, Guangzhou, Shenzhen, Shanghai, and Xinjiang have established clinical translation centers for brain-computer interfaces. The technology is accelerating from laboratory research to practical application.

At the market level, the total number of brain-computer interface companies in China has exceeded 200. China Galaxy Securities compiled a list of 21 brain-computer interface component stocks covering six major industries, with 14 in the pharmaceutical and biological sector, accounting for about 67%.

The capital market’s enthusiasm for the brain-computer interface sector continues to rise. On March 13, Jiatie Medical announced a strategic financing of 500 million yuan, with a total financing amount exceeding 1.1 billion yuan in nearly a year; on March 12, Gestalt Technology, founded just over three months ago, announced the completion of a 150 million yuan angel round, setting a new record for angel funding in China’s brain-computer interface field.

According to CCID Consulting data, the market size of China’s brain-computer interface industry is projected to reach 3.2 billion yuan in 2024, with an 18.8% growth rate; by 2028, it is expected to reach 6.14 billion yuan, with a compound annual growth rate of 17.7% from 2024 to 2028.

As one of the six key future industries supported by the country, with the gradual implementation of national and local policies, building a full-chain innovation system has become an important direction for the development of the brain-computer interface industry.

Zhang Chang, Vice President and Chief Development Officer of HealthTong, previously told 21st Century Business Herald that the underlying logic of building a full-chain innovation system for brain-computer interfaces involves three levels: first, scientific research and technological realization; second, clinical validation; and third, large-scale manufacturing. These three levels will determine the height, speed, and breadth of innovation.

“Level one focuses on talent in basic and translational sciences, systems and capabilities, as well as closed-loop engineering manufacturing. This involves education, scientific research strategic planning, and implementation; level two acts as a validation funnel, where China’s clinical capabilities are currently leading globally. Future focus may shift to data elements and how intelligent technologies empower this process; level three tests precision manufacturing, modern production capacity, and supply chain support, which are China’s industrial advantages. With continuous improvement of the innovation system, these advantages will further emerge,” Zhang said.

Undoubtedly, China’s brain-computer interface industry is accelerating toward maturity, with the potential to continuously create value in neural rehabilitation, human-machine interaction, and other fields, leading global development in brain-computer interface technology and industry.