"If major regulatory reforms are not carried out, in 10 years, if a wealthy American wants to receive the most advanced cancer treatment, the only option might be to go to China."
On June 10 local time, Max Hodak, founder of the American brain-computer interface company Science and former president of Neuralink under Elon Musk, issued the aforementioned warning at the Semafor summit held in San Francisco.
In his view, the United States is facing the real risk of being overtaken by China in the field of life sciences. If there is no acceleration in medical research and regulatory system reforms, the country may lose its leading position in global medical and scientific innovation to China in the future. Hockdack pointed out that China is doing “very well” in this regard, and the United States should be “highly vigilant” about this situation.
As an industry insider who has been engaged in brain-computer interface research for a long time, Hodak's statement is not baseless. In March of this year, the National Medical Products Administration of China approved the marketing of the NEO system, a prosthetic hand movement function compensation system developed by BrainCo Medical Technology (Shanghai) Co., Ltd. in collaboration with the team from Tsinghua University.
European technology news website The Next Web (TNW) reported on the 8th of this month that this is the first time in the world that a national regulatory agency has approved the commercialization of implantable brain-computer interfaces.
This breakthrough is due to China's continuous efforts in deploying strategic emerging industries in recent years. China has identified brain-computer interfaces as one of the six strategic future industries, and has set a goal of reaching world-leading levels in brain science technology by 2030. A number of Chinese startup companies specializing in brain-computer interfaces have rapidly emerged under this strategy.
A man is undergoing hand function rehabilitation training using brain-computer interfaces. IC Photo
Reports say that the brain-computer interface competition has now evolved into a geopolitical game. Chinese companies, with support from Chinese policies, can quickly obtain approvals, allowing their innovative technologies to enter clinical application more quickly. Meanwhile, American companies are faced with the Food and Drug Administration (FDA) in the United States, which is becoming less willing to approve new technologies. Although American companies started early, their development is increasingly restricted by regulatory systems.
Currently, there are no brain-computer interface products in the United States that have been officially introduced into commercial use. All implantation procedures are still limited to research projects or special access programs.
Neuralink has implanted its N1 brain-computer interface device on at least 21 patients under the research project framework. The first subject has demonstrated the ability to play chess, browse web pages, and control computer cursors solely through thought. However, Neuralink has not yet obtained a commercial sales license. The company plans to expand its production capacity in 2026 and achieve nearly fully automated implant surgeries. Nevertheless, it will still take several years before it can obtain FDA approval for commercial sales.
Another American company, Synchron, has a Stentrode brain-computer interface system that can be implanted via the jugular vein, without the need for craniotomy. This is the first company to receive an exemption from the FDA for permanent implantable brain-computer interface devices. They are using $200 million in Series D financing to advance this year's critical clinical trials.
Precision Neuroscience has taken a different approach. In April 2025, it obtained FDA's 510(k) approval process and collaborated with Medtronic of the United States to integrate its brain-computer interface technology into existing neurosurgical systems.
Over the past few decades, the United States has been regarded as a leader in the development of brain-computer interfaces worldwide. It has continuously invested in high-risk, high-reward technological breakthroughs, hoping to fundamentally change medical technology and the direction of human-machine integration. However, what was unexpected is that China was the first to cross the finish line.
Brain-computer interfaces are technological systems that can record brain activity or neural signals, and use these to control external devices such as prosthetic limbs, wheelchairs, or computer cursors. The goal of these interfaces is to help patients with motor dysfunction, such as those with paralysis, regain the ability to move.
Its development has long faced a difficult technical dilemma: non-invasive solutions place sensors outside the scalp, which offer higher safety, but due to the skull blocking signals, the collection accuracy is relatively limited. Implantable solutions directly implant sensors into the cerebral cortex, allowing for higher precision neural signals, but in the long term, they may face challenges such as electrode displacement and biocompatibility issues.
According to a March report by the Hong Kong-based South China Morning Post, Neuralink has chosen the second approach. The challenges it faces highlight some safety issues associated with the commercialization of implantable devices. In 2024, about one month after the first patient underwent a Neuralink implantation procedure, the function of the device significantly declined due to 85% of the implanted electrodes becoming retracted or displaced. Neuralink has adjusted the system to make it capable of responding to the remaining electrodes, but electrode retraction remains a potential long-term functional issue.
China's first approved NEO system adopted a technology route that lies between implantable and non-implantable options. Reports indicate that this approach is seen to align with the Confucian concept of 'the Doctrine of the Mean,' which seeks a balance between safety and precision. This allowed the Chinese team to be the first in the world to launch a commercially approved brain-computer interface product, leading all other participants, including those from the United States.
At the Semafor summit, Hawardk admitted that brain-computer interfaces "sound crazy and difficult to take seriously," but their potential impact is so significant that it's hard to imagine they wouldn't be a focus of national development strategies.
He said that in the next decade, brain-computer interface technology is likely to become one of the ‘three to four most important areas of global technological competition’, and ‘China has fully recognized its tremendous potential’.
