Behind the 'World's First Approval': The Quietly Intensifying US-China Race for Brain-Computer Interface Supremacy

[By Observer Network, Mind Observation Institute]

On March 13, an approval document issued by the National Medical Products Administration (NMPA) gave a significant boost to the brain-computer interface (BCI) industry. The NEO, an implantable BCI system for compensating hand motor function developed by NeuroXess Medical Technology (Shanghai) Co., Ltd., has officially received registration certification as a Class III medical device, becoming the world’s first approved invasive BCI product to enter the market.

This registration certificate, hailed by the industry as the “world’s first approval,” not only marks the formal transition of brain-computer interface (BCI) technology from scientific research and experimentation to clinical commercialization, but also adds a significant chapter to the narrative of the US-China BCI race. In this field, once defined by Elon Musk’s Neuralink, it is a Chinese company that has taken the lead in completing the regulatory loop and securing the “passport” to commercialization.

Yet beyond the applause, sobering questions remain unavoidable: Does this first certification truly signify that China has taken the lead in the field of brain-computer interfaces (BCIs), or merely that it has gained an early advantage along a specific technological pathway? How significant is the gap between Chinese and U.S. enterprises in critical areas such as core hardware, underlying algorithms, and autonomous, controllable supply chains? Amidst the capital frenzy driven by numerous companies queuing up for initial public offerings (IPOs), is the industrial foundation sufficiently robust?

The Debate Over Technical Approaches: Safety First or Performance First?

To address these questions, it is helpful to first examine the technical approach adopted by BrainCo’s NEO system. NEO utilizes a minimally invasive epidural implantation strategy, wherein electrodes are placed on the surface of the dura mater rather than being inserted deep into brain tissue. The core advantage of this approach lies in its safety profile: it avoids the inflammatory responses and tissue damage potentially associated with direct contact with brain parenchyma. The surgical procedure closely resembles conventional neurosurgical operations for clinicians, and patients can resume independent home use within one month postoperatively.

Clinical data indicate that NEO has completed 36 surgical procedures, including 32 cases in a multicenter confirmatory clinical trial. All participants achieved brain-controlled grasping assistance, and some even exhibited signs of neural remodeling—spontaneous recovery of unassisted grasping ability, which had been completely lost, was observed after the device was turned off. This unexpected finding provides valuable clinical evidence for the evolution of brain-computer interfaces from “functional compensation” to “neural repair.”

However, there are also dissenting voices among peers. Theoretically, the signal acquisition quality of epidural schemes is inferior to that of schemes involving direct electrode implantation into the cerebral cortex. Neuralink adopts the latter approach: its N1 chip, via surgeryRobotDirectly implanting thousands of flexible electrode threads, each finer than a human hair, into brain tissue enables high-density neural signal acquisition across 1,024 channels. This approach offers signal resolution and information throughput far superior to epidural pathways; however, it comes at the cost of increased surgical complexity and greater challenges in long-term biocompatibility. Noland Arbaugh, the first human patient to receive a Neuralink implant, experienced retraction and detachment of half of his electrode threads. Although this issue was subsequently compensated for through software algorithms, the incident exposed profound engineering reliability challenges inherent in invasive brain-computer interfaces.

In other words, BrainCo’s “world’s first certification” is more accurately described as a pioneering breakthrough in the specific technical pathway of semi-invasive brain-computer interfaces. Compared with deeply invasive approaches such as Neuralink’s, these two routes are not simply a matter of one being superior to the other; rather, they represent different bets on “safety-first” versus “performance-first” priorities. The Chinese team opted for the former, while the American team leaned toward the latter, reflecting differences between the two countries in regulatory philosophy for medical devices, clinical culture, and industrial strategy.

Industrial Race: China’s “Acceleration” Driven by Policy

In China, the speed and intensity of policy-driven initiatives are evident. The 2026 Government Work Report lists brain-computer interfaces (BCIs) alongside quantum technologies, embodied intelligence, and 6G as future industries explicitly prioritized for national development; the Outline of the 15th Five-Year Plan further establishes BCIs as a key direction for future industrial growth. The National Medical Products Administration (NMPA) has adopted a review principle of “early intervention, company-specific strategies, comprehensive guidance, and integrated research and evaluation” for BCI products, thereby creating an institutional pathway that facilitated the rapid approval of NeuroBooster’s products.

In early 2025, Shanghai took the lead in releasing the “Shanghai Action Plan for Cultivating the Future Brain-Computer Interface Industry (2025–2030),” becoming the first provincial-level government in China to approve a special action plan dedicated to brain-computer interfaces (BCIs). During the same period, China’s first BCI future industry cluster, “Brain-Intelligence World,” was established in Shanghai. The Hangzhou healthcare security authorities added new medical service pricing items, including fees for the implantation of invasive BCIs. Beijing, Shandong, and Sichuan also successively introduced specialized industrial policies. From top-level design to local implementation, a top-down policy network is rapidly expanding.

The intensity of such industrial cultivation has, to some extent, been the core driving force enabling Chinese brain-computer interface (BCI) enterprises to catch up rapidly. Statistics show that Shanghai alone has gathered nearly 60 BCI companies to date, covering the three major technological pathways: invasive, semi-invasive, and non-invasive. Globally, approximately 10 BCI companies have entered clinical trials, with China and the United States each accounting for half; among these, Shanghai holds three spots—NeuroXess, Step Medical, and BrainCo. In 2025, financing cases in Shanghai’s BCI sector accounted for 36.4% of the national total, while the financing amount reached a significant 53.7%. The combination of capital enthusiasm and policy support has propelled Shanghai to become one of the core global hubs for BCI innovation within just a few years.

The “2025 Brain-Computer Interface Conference” was successfully held in Shanghai on December 4–5, 2025

In this increasingly crowded field, companies are adopting differentiated technological strategies. Unlike Bonree康’s epidural approach, Jieti Medical has pursued an invasive route, independently developing ultra-flexible electrodes with a diameter just one-hundredth that of a human hair and the world’s smallest wireless brain-computer interface (BCI) implant. Earlier this year, Jieti Medical completed China’s first clinical implantation of a 256-channel invasive BCI, and its wireless high-throughput system has entered the National Medical Products Administration (NMPA) review process.Innovative Medical CareThe medical device “Green Channel” is scheduled to launch large-scale, multi-center registrational clinical trials by mid-year, with nearly 40 implantation surgeries to be completed within the year. The goal is for the total number of clinical implants to approach or even surpass Neuralink’s current cumulative total of approximately 21 cases in its clinical trials by year-end. On the same day that BrainCo received regulatory approval, Steady Medical officially announced the completion of a RMB 500 million strategic financing round, led by Alibaba and participated by SDIC Chuanghe, while existing shareholders including Tencent, Qiming Venture Partners, and Lilly Asia Ventures all increased their investments. This makes Steady Medical the first company in the brain-computer interface sector to receive bets from both internet giants, Alibaba and Tencent.

NeuroXess has achieved a breakthrough in another highly challenging direction: the world’s first prospective clinical trial for real-time decoding of the Chinese language. As a tonal language, Chinese presents decoding difficulties far exceeding those of alphabetic languages such as English. NeuroXess has filled the global gap in real-time brain-computer interface (BCI) decoding for tonal languages with its “Chinese solution.” Meanwhile, Shenfu Jianxing, a company leveraging scientific and technological achievements from Fudan University, has completed the first batch of investigator-initiated trials (IITs) in China for its globally pioneering “triple-integration” brain-spine interface technology. This product has entered the U.S. FDA’s “Breakthrough Device” pathway, signifying that China’s independently developed BCI technology has gained recognition from the world’s most stringent medical device regulatory system.

In the non-invasive segment, products from Shanghai-based enterprises such as Shuli Innovation, Siyi Intelligence, and Aoyi Technology have been applied in scenarios including stroke rehabilitation, depression screening, and insomnia diagnosis and treatment, achieving sales at the scale of tens of millions of yuan. BrainCo, leveraging consumer medical products such as intelligent bionic hands and EEG-based sleep aids, completed approximately RMB 2 billion in financing early this year and formally submitted an application for an initial public offering (IPO) on the Hong Kong Stock Exchange, marking the second-largest financing event globally in the brain-computer interface (BCI) sector after Neuralink. Regarding NeuroXess, reliable sources indicate that the company completed its IPO tutoring registration with regulatory authorities in February 2026, with its sponsoring broker beingCITIC Securities, officially launching the listing process on the STAR Market.

List of Mainland China Brain-Computer Interface Companies Planning IPOs/Key Candidates Under Review (Compiled by Mind Observatory)

The simultaneous IPO bids by two Chinese brain-computer interface (BCI) companies are undoubtedly a hallmark signal of the industry’s heating up. However, beneath the enthusiastic reception from capital markets, the deep-seated concerns within the industry also warrant serious attention.

Behind the Glamour: Hidden Concerns and the Path Forward

The most critical issue lies in the autonomous and controllable supply of key upstream components. The brain-computer interface (BCI) industry chain exhibits a distinct "dumbbell-shaped" structure: downstream application enterprises account for 70%, midstream system integrators approximately 20%, while upstream core component manufacturers constitute only 10%. It is precisely this 10% that forms the highest barrier across the entire industry chain. For core devices that determine the performance ceiling of BCI products—such as high-precision implantable electrodes, specialized neural signal acquisition chips, and biocompatible encapsulation materials—Chinese companies still have relatively weak technical accumulation, with some key components remaining dependent on imports.

The United States is home not only to integrated system companies such as Neuralink, Synchron, and Precision Neuroscience, but also to suppliers specializing in upstream core components, including ClearPoint Neuro (neurosurgical navigation systems) and NeuroOne (thin-film electrode technology), thereby forming a more comprehensive technological matrix. Should US-China technological friction extend into the biomedical device sector, vulnerabilities within the supply chain will be rapidly exposed. Although Chinese enterprises have made progress—for instance, Wuxi Deep Brain Medical has completed the development of a 4,096-channel electrophysiological recording system, and Yuansi Technology has achieved independent control over high-precision EEG acquisition systems—domestic substitution remains in its early stages overall, with a considerable distance still to go before establishing a reliable, closed-loop supply chain.

Underlying algorithms represent another critical gap that needs to be addressed. The core function of brain-computer interfaces (BCIs) lies in "decoding"—translating complex neural electrical signals into clear motor intentions or language commands. This relies on highly sophisticated signal processing algorithms and machine learning models. The United States has more extensive research accumulation in this field; Neuralink’s adaptive calibration algorithm has reduced user training time from several hours to just a few minutes, and its real-time decoding capability enables patients to perform complex tasks such as controlling cursors, typing, playing games, and operating robotic arms through thought alone.

Although Chinese teams have achieved notable breakthroughs in specific scenarios (such as BrainCo’s Chinese language decoding), objective gaps remain compared to their U.S. counterparts in fundamental metrics, including general decoding capability, cross-subject generalization performance, and long-term signal stability. In 2025, China filed 1,842 core algorithm patents for brain-computer interfaces, accounting for 37% of the global total and surpassing the United States for the first time to become the largest producer of such patents. However, leadership in patent quantity does not equate to leadership in technical performance, particularly in “soft power” aspects that are difficult to measure through patents, such as clinical-grade decoding accuracy and robustness.

From the perspective of capital markets, the IPO frenzy among Chinese brain-computer interface (BCI) companies is likewise a double-edged sword. NeuroXess’s push for a listing on the STAR Market, BrainCo’s bid for the Hong Kong stock exchange, coupled with Jieti Medical receiving backing from both Alibaba and Tencent, have driven industry valuations ever higher. The A-share BCI concept sector surged sharply in late trading on the day NeuroXess received approval, with Innovative Medical andSanbo Brain Hospital、Yingkang LifeSeveral stocks surged sharply. However, it must be noted that most of these listed companies are not core players in the brain-computer interface (BCI) sector, but rather “followers” that have entered the segment through equity stakes, partnerships, or conceptual associations.

Significant divergence is evident among industry players: while some are “doers” diligently tackling core technologies, others are speculators leveraging concept hype without substantive strategic layouts. The true core assets in China’s brain-computer interface (BCI) sector remain concentrated in the hands of a few companies in the primary market, such as NeuroXess, Jieti Medical, TaoBionic, and BrainCo. To what extent the frenzy in the secondary market reflects genuine industrial value remains questionable.

The pace of commercial implementation also warrants attention. Xu Honglai, founder of BrainCo, candidly admitted to feeling “immense pressure” after receiving regulatory approval, stating that “obtaining the certificate is merely the beginning.” The first batch of clinical applications for the NEO product is expected to be carried out in Grade A tertiary hospitals that have already completed clinical validation, with the goal of achieving the first formal clinical application in patients within the year. However, between obtaining certification and large-scale hospital adoption lie a series of complex steps, including product pricing, inclusion in medical insurance coverage, surgeon training, and patient education. The per-case cost of brain-computer interface (BCI) surgery remains high. The founder of the U.S. company Synchron has bluntly stated that full commercialization of medical BCI applications is still estimated to take 3 to 5 years, while consumer-grade implantable devices will require 15 to 20 years.

One of China’s advantages lies in its vast patient population. The pool of eligible patients with quadriplegia resulting from cervical spinal cord injury alone is considerable. Another advantage stems from institutional innovations, such as the inclusion of brain-computer interfaces in medical insurance pricing schemes, pioneered in cities like Hangzhou. However, reducing manufacturing costs to an affordable level for patients while ensuring quality remains the next major hurdle that companies like NeuroXess must overcome.

Meanwhile, competitors across the ocean have not slowed their pace. At the beginning of the year, Elon Musk announced that Neuralink would commence large-scale mass production in 2026 and transition to a nearly fully automated surgical process. Neuralink currently has approximately 20 participants in its clinical trials and has expanded its clinical footprint from the United States to the United Kingdom, Canada, and the United Arab Emirates. In May 2025, Neuralink’s speech restoration technology became the third product to receive FDA Breakthrough Device designation. Its Blindsight project, launched in 2026, extends the application of brain-computer interfaces from motor control to visual reconstruction. Neuralink’s technology roadmap indicates plans to achieve synchronous reading of motor, language, and visual signals by 2027, and to explore deep integration with artificial intelligence by 2028. In other words, Neuralink is evolving from single-function restoration toward a “whole-brain interface platform,” with ambitions extending far beyond medical devices to the ultimate form of human-machine convergence.

This divergence in strategic landscape may be the more noteworthy dimension in the brain-computer interface (BCI) competition between China and the United States. Chinese companies generally anchor their technological pathways in medical rehabilitation, emphasizing safety, clinical accessibility, and regulatory compliance—an undoubtedly pragmatic and responsible choice. However, Neuralink’s narrative scope has far transcended the realm of medical devices. In recent public interviews, its co-founder Max Hodak discussed topics such as biohybrid interfaces, “consciousness longevity,” and even the notion that “the first people to live to 1,000 years old may already have been born,” thereby defining brain-computer interfaces as the next operating system for human civilization.

While this narrative undoubtedly carries a Silicon Valley-style flair for exaggeration, it has undeniably secured $9 billion in valuation-backed capital support for Neuralink, along with attracting the world’s top engineering and neuroscience talent. Whether Chinese enterprises can craft a compelling long-term technological vision beyond the pragmatic approach to medical devices will directly impact their competitiveness in the global talent and capital markets.

As of 2026, the true landscape of China’s brain-computer interface (BCI) industry is complex and multi-layered. NeuroXess’s “world’s first certification,” Step Medical’s substantial financing round, BrainCo’s breakthrough in language decoding, and Shenfu Jianxing’s FDA designation—these impressive achievements demonstrate that Chinese teams have ascended to the first tier of the global BCI race. With nearly 60 companies and more than half of the total financing, Shanghai has taken the lead in building a full-chain ecosystem spanning from core components to clinical translation, making the “Shanghai Model” a benchmark for cultivating cutting-edge industries worldwide.

However, the domestic substitution of upstream core components remains incomplete, and the engineering capability for underlying decoding algorithms still requires improvement. A significant disparity exists between the conceptual hype in the secondary market and the actual progress in the primary market. The final stage of commercialization is fraught with practical challenges, including pricing, health insurance coverage, cost control, and surgeon training.

The global brain-computer interface (BCI) market size is projected to grow from $2.62 billion in 2024 to $12.4 billion in 2034, representing a nearly fivefold increase over the decade. This substantial growth potential provides ample room for the parallel exploration of different technological pathways by China and the United States. However, the harsh reality of industrial competition is that the true winners are often not those who secure the first regulatory approval, but rather those who continuously accumulate advantages in technological iteration, supply chain integration, talent acquisition, and global strategic layout. China’s BCI industry has already demonstrated its ability to “keep pace,” yet the distance from “keeping pace” to “taking the lead” is far greater than what can be measured by a single registration certificate. This industrial war for the brain has only just begun.

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