Don't just focus on Musk; China's plan has already overtaken in a different way.

(Source: Medical Device Innovation Network)

On March 13, 2026, the National Medical Products Administration approved the registration application for Bioraykang Medical Technology (Shanghai) Co., Ltd.'s innovative product, the “Implantable Brain-Computer Interface Hand Motor Function Compensation System.” This marks the world’s first invasive brain-computer interface medical device officially entering clinical application, representing a key leap for China from “following” to “leading” in this cutting-edge field.

From technological breakthroughs to product implementation,

China’s solution for invasive BCI

Before this approval, global attention on invasive brain-computer interfaces was almost entirely focused on Elon Musk’s Neuralink. However, under the spotlight, there are shadows. Shortly after Neuralink completed its first human implantation, foreign media reported a failure rate of up to 85% for its flexible electrode wires. This incident directly triggered industry-wide concerns about the long-term stability of invasive brain-computer interface technology.

This event exposed a common challenge in invasive BCIs: the brain is not static; it pulsates rhythmically with breathing and heartbeat. Traditional linear electrodes cannot adapt in real-time to changes in brain tissue, making displacement or even extrusion easy, which not only reduces signal accuracy but may also cause inflammation.

Faced with this core bottleneck, Chinese research teams have proposed different solutions.

On one hand, recent results published by Fang Ying’s team at the Beijing Institute of Brain Science and Brain-Inspired Intelligence in Nature Electronics show they have successfully developed a stretchable flexible electrode. This electrode, fabricated through precise micro-nano processing, is first made into a spiral array on a 2D plane. When implanted into the brain, it unfolds like a “cut paper window decoration” in the cerebrospinal fluid environment, dynamically following brain pulsations. Experiments show that stretching this electrode by 100 micrometers requires only 37 micro-Newtons of force—just 1/100 of what Neuralink’s linear electrodes need—its ultra-soft nature fundamentally reduces mechanical damage to brain tissue.

On the other hand, the approved Bioraykang product and the upcoming clinical trial registration of “Beijing Brain No. 1” represent another approach emphasizing clinical safety: minimally invasive “extracranial micro-invasive implantation.”

“Beijing Brain No. 1” uses a flexible thin film electrode only 6 micrometers thick (about 1/15 of a human hair), precisely placed on the surface of the dura mater over functional brain areas. This approach does not penetrate the dura, which may slightly reduce signal precision compared to intracortical implants but greatly lowers the risk of brain tissue damage and postoperative rejection, striking a better balance between safety and efficacy suitable for large-scale clinical promotion.

Industrial ecosystem rising,

From “single-point breakthroughs” to “full-chain competition”

The approval of Bioraykang’s product is not an isolated scientific achievement but reflects the comprehensive rise of China’s brain-computer interface industry ecosystem. If 2025 was a year of technological validation, 2026 is undoubtedly the critical year for commercialization.

Capital markets are highly perceptive. Since the beginning of the year, good news has been frequent in the BCI field: Strong Brain Technology completed a new round of approximately 2 billion yuan in financing—second largest globally in the field; Brain Tiger Technology’s “Super Factory” broke ground in Ganjiang New Area, Jiangxi, marking a key step from laboratory research to mass production, tasked with producing China’s first “fully implantable, wireless, full-function” brain-computer interface system.

From an industry chain perspective, the competitive landscape is becoming clearer. According to Wanlian Securities, the global competition pattern is “led by the US in invasive, China leading in non-invasive.” However, Chinese companies are accelerating in the invasive domain.

[AI-generated image]

Currently, several listed companies in the A-share market are deeply involved. Sanbo Brain has previously completed invasive BCI surgeries at its Fujian branch; Yingjixin’s IPA1299 chip is in mass production for EEG signal collection; Hanwei Technology has made breakthroughs in flexible micro-nano sensors and implantable flexible neural electrode materials. These upstream core devices, chips, and algorithms are building China’s autonomous technological foundation for BCIs.

Competitive analysis:

Two-pronged approach: medical and consumer markets

A detailed analysis shows that the commercialization path of BCIs follows a clear “double-curve” pattern.

On one side is the serious medical “urgent need curve.” This is also the main focus of current invasive technology. Bioraykang’s product targets patients with C2–C6 cervical spinal cord injuries, helping them achieve hand grasp function compensation. The clinical data for “Beijing Brain No. 1” is equally encouraging: Xiao Wang, a patient with lower limb paralysis, after implantation and combined spinal cord stimulation with exoskeleton training, improved from the most severe (Grade A) to Grade C in spinal cord injury scores, and can now stand and walk with a powered exoskeleton. In this field, products directly address the “restoration of function” needs, with strong willingness to pay, but clinical validation takes time and barriers are high. Major domestic players include Bioraykang, Brain Tiger, and ChipZhida, all deeply collaborating with top neurosurgical centers.

On the other side is the consumer market’s “inclusive curve.” This route mainly uses non-invasive technology, which is technically easier, safer, and cost-controlled, rapidly penetrating education, health care, entertainment, and other scenarios. Companies like Cofu Medical and Xiangyu Medical have taken the lead. Xiangyu Medical’s BCI rehabilitation product matrix covers upper and lower limb training, exoskeleton robots, and more, transforming rehabilitation devices from “assistive tools” into “precise treatment carriers.” This market is highly competitive, with risks of product homogenization, but the broad market space is fundamental for early industry development.

It’s worth noting that the invasive approach, as a middle route, is being explored by teams like Nankai University’s Duan Feng, which uses vascular stents to deliver electrodes into the brain—combining minimally invasive advantages with signal quality. If clinical progress is smooth, a tripartite competition may emerge in the future.

Challenges remain, and the future is already here

Despite frequent good news, we must remain clear-eyed about the many challenges facing the BCI industry.

First is the gap between technology and clinical translation. Moving from “research prototypes” to “mature medical products” requires crossing the “last mile,” which involves not only technical optimization but also establishing standards and streamlining processes. Fudan University’s Associate Researcher Jia Fumin states that BCI is a typical interdisciplinary field, and traditional medical institutions and research institutes need to break down professional barriers.

Second are cost and market perception constraints. Currently, invasive devices are expensive to produce, making products less affordable. Meanwhile, consumers still fear the safety of invasive devices and doubt the performance of non-invasive ones.

Third are ethical and data security risks. EEG data, as the most private biological information, lacks comprehensive legal regulation in collection, storage, and use. China currently has limited influence in shaping international BCI ethical standards.

Nevertheless, we are standing at a new starting point. The national “14th Five-Year Plan” explicitly includes BCI as a future industry. The government work report mentions fostering and developing a batch of future industries, including BCI. Cities like Shanghai, Beijing, and Jiangsu have introduced action plans, providing comprehensive support from clinical platform construction and medical insurance pricing to talent recruitment.

For China’s medical device industry, the blue ocean of BCI has just begun to stir. Who can lead this race across the “valley of death” depends not only on technological depth but also on precise insight and respect for real clinical needs.

▲Source: Medical Device Innovation Network

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