China has approved the world’s first invasive brain-computer chip—here’s what’s next

中国批准全球首款侵入式脑机接口芯片——接下来会发生什么？

EXECUTIVE SUMMARY 执行摘要

One day last October, sitting in the courtyard of his house in China’s Henan province, Dong Hui decided to see if he could hold a pen to write. Dong, 39, had sustained spinal cord injuries in a car accident six years earlier that left him paralyzed from the neck down. Slowly but determinedly, he wrote his name, “Thank you,” and then the date. This was the result of an 11-month-long rehabilitation enabled by an implant in his brain. Before that process, Dong could move his arms slightly but wasn’t able to use his fingers. “I couldn’t believe I was able to write again. I was so excited I even missed a stroke in my name,” he told MIT Technology Review on a video call. 去年10月的一天，坐在中国河南省家中的院子里，董辉（音译）决定试着握笔写字。39岁的董辉在六年前的一场车祸中脊髓受损，导致颈部以下瘫痪。他缓慢而坚定地写下了自己的名字、“谢谢”，以及日期。这是他通过脑部植入设备进行11个月康复训练后的成果。在此之前，董辉的手臂只能轻微活动，但无法使用手指。“我简直不敢相信自己又能写字了。我太激动了，甚至在写名字时还少写了一笔，”他在视频通话中告诉《麻省理工科技评论》。

In November 2024, Dong became one of the first people in China to be given an invasive brain-computer interface (BCI) through brain surgery. He had signed up for a clinical trial with the device’s developer one month after seeing on TV how a BCI had apparently enabled another paralyzed Chinese man to hold his granddaughter. This March, the implant Dong uses became the first invasive BCI product in the world to be approved for use beyond clinical trials. It’s now available to some patients with paralysis in their limbs due to spinal cord injuries. We spoke to a range of experts to understand why the device was able to reach this global milestone, what makes this moment so significant, and what to expect next. 2024年11月，董辉成为中国首批通过脑部手术植入侵入式脑机接口（BCI）的人之一。此前，他在电视上看到另一位瘫痪的中国男子通过脑机接口抱住了孙女，一个月后，他便报名参加了该设备开发商的临床试验。今年3月，董辉使用的植入物成为全球首款获批用于临床试验之外的侵入式脑机接口产品。目前，该产品已可供部分因脊髓损伤导致肢体瘫痪的患者使用。我们采访了多位专家，以了解该设备为何能达到这一全球里程碑，这一时刻的意义何在，以及未来有何期待。

A world first 全球首创

Dong’s brain implant is a coin-size device called NEO. It was developed by Neuracle Technology, a Shanghai-based startup, together with researchers at Tsinghua University in Beijing. During a procedure that took just over an hour and a half, the device’s sensors, which collect Dong’s brain signals, were placed on his dura mater, the tough outer layer of tissue that covers and protects the brain. The signals are transmitted to a computer by an implant placed on Dong’s skull. The computer then translates the signals into commands for a soft robotic glove Dong wears during the 2.5-hour training sessions he completes each day to help him learn to grab. 董辉的脑部植入物是一个名为NEO的硬币大小的设备。它由上海初创公司博睿康科技（Neuracle Technology）与清华大学的研究人员共同开发。在仅一个半小时的手术中，该设备的传感器被放置在董辉的硬脑膜上（覆盖并保护大脑的坚韧外层组织），用于采集他的脑信号。这些信号通过放置在董辉颅骨上的植入物传输到计算机。随后，计算机将信号转化为指令，控制董辉每天进行2.5小时训练时所佩戴的软体机械手套，帮助他学习抓握。

Dong started his rehabilitation around a week after surgery. “On the ninth day of my training, my right hand successfully grabbed a ball without the glove,” he says. “That was a miraculous moment.” Now he continues with his training at home. He wants to be able to control his hands better in order to put on clothes, eat, and do other daily tasks without troubling his aging parents. 术后约一周，董辉开始了康复训练。“训练的第九天，我的右手在没有佩戴手套的情况下成功抓起了一个球，”他说，“那是一个奇迹般的时刻。”现在，他继续在家中进行训练。他希望能够更好地控制双手，以便自己穿衣、吃饭，并完成其他日常任务，不再给年迈的父母增添负担。

A growing number of people with traumatic injuries in China are now poised to tread a similar path thanks to NEO’s recent approval. According to China’s National Medical Products Administration, the bureau responsible for drug supervision, the product is suitable for patients between 18 and 60 who have paralysis in all limbs due to spinal cord injuries but still have some residual function in their arms. NEO beat several other BCIs to approval, including one from Neuralink, a California-based company founded by Elon Musk. 得益于NEO近期获批，中国越来越多的创伤性损伤患者有望走上类似的康复之路。据负责药品监管的国家药品监督管理局称，该产品适用于18至60岁、因脊髓损伤导致四肢瘫痪但手臂仍有部分残余功能的患者。NEO在获批速度上领先于其他多款脑机接口产品，其中包括埃隆·马斯克创立的加州公司Neuralink的产品。

Since October 2023, Neuracle has conducted 36 clinical trials using NEO, including the one on Dong. Thirty-two of them took place in the space of a few months in 2025, with the details about one of the four first in-person trials published in a preprint paper last July. Neuracle did not reply to a request for comment from MIT Technology Review. 自2023年10月以来，博睿康科技已使用NEO进行了36项临床试验，其中包括董辉参与的那项。其中32项试验是在2025年的几个月内完成的，四项首批人体试验中有一项的详细信息已于去年7月发表在预印本论文中。博睿康科技未回复《麻思理工科技评论》的置评请求。

One reason for NEO’s fast approval could be that it has a “relatively less invasive” design than counterparts such as Neuralink’s N1 brain chip, says Avinash Singh, a BCI researcher at the University of Technology Sydney. NEO’s eight sensors sit on top of the brain’s protective membrane while Neuralink’s N1 chip directly penetrates the cortex, the outermost layer of the brain itself. Neuracle’s device faces fewer regulatory constraints because it presents a lower risk of hemorrhage, glial scarring, and long-term signal degradation, Singh says. China’s strong support for its BCI industry also means that NEO was put on an expedited regulatory pathway; in comparison, the approval process of the US Food and Drug Administration can take several years, Singh adds. 悉尼科技大学的脑机接口研究员阿维纳什·辛格（Avinash Singh）表示，NEO获批速度快的一个原因可能是其设计比Neuralink的N1脑芯片等同类产品“侵入性相对较小”。NEO的八个传感器位于大脑保护膜之上，而Neuralink的N1芯片则直接穿透大脑最外层的皮层。辛格指出，博睿康的设备面临的监管限制较少，因为它导致出血、胶质瘢痕和长期信号衰减的风险较低。辛格补充说，中国对脑机接口产业的强力支持也意味着NEO被纳入了快速审批通道；相比之下，美国食品药品监督管理局（FDA）的审批过程可能需要数年时间。

A big boost for BCIs 脑机接口的巨大推动力

NEO’s approval is hugely important for the global BCI industry, says Wang Shouyan, a neuroscientist at Fudan University in Shanghai who was not involved in research or trialing for NEO. Even though research and development on BCIs has taken place for several decades, most of it happened in the lab. The news means that BCIs are now ready for large-scale manufacturing and clinical use in China, Wang says. For Dong, however, it means something much more personal. “Now, it will be able to help not only me, but also thousands and thousands of other patients suffering from spinal cord injuries in China who are tortured by despair each day,” he says of NEO. “It will bring them hope and change their lives.” 上海复旦大学的神经科学家王守岩（未参与NEO的研究或试验）表示，NEO的获批对全球脑机接口行业意义重大。尽管脑机接口的研发已经进行了几十年，但大部分仍停留在实验室阶段。王守岩认为，这一消息意味着脑机接口在中国已准备好进行大规模制造和临床应用。然而，对董辉来说，这有着更个人的意义。谈到NEO，他说：“现在，它不仅能帮助我，还能帮助中国成千上万每天被绝望折磨的脊髓损伤患者。它将带给他们希望，改变他们的生活。”

Days after NEO was approved, China started incorporating it into the country’s health insurance system by assigning it a unique code. This is one of the first steps toward a future where eligible Chinese patients pay a certain percentage of the BCI’s price if they need it during their treatment. The growth of China’s BCI industry is expected to accelerate thanks to the government’s policy support and financial backing. The country’s latest five-year plan, published on the same day Neuracle received its approval, lists BCI as one of six key industries important to China’s future tech competitiveness, alongside quantum technology, humanoid robots, and others. Several Chinese startups, including NeuroXess and StairMed, have already worked in the field for many years. “China’s decision to double down on becoming a global leader in the field owes in part to what these companies have already accomplished,” says Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign who studies information and technology policy. But, Sun says, the biggest advantage China may have is that Chinese people, particularly patients like Dong, are… 在NEO获批几天后，中国开始通过为其分配唯一代码，将其纳入国家医保体系。这是迈向未来的第一步，未来符合条件的中国患者在治疗中需要该设备时，只需支付一定比例的费用。得益于政府的政策支持和资金投入，中国脑机接口产业的增长预计将加速。在博睿康获得批准的同一天，中国发布的最新五年规划将脑机接口列为关乎中国未来科技竞争力的六大关键产业之一，与量子技术、人形机器人等并列。包括脑虎科技（NeuroXess）和阶梯医疗（StairMed）在内的多家中国初创公司已在该领域深耕多年。伊利诺伊大学厄巴纳-香槟分校研究信息与技术政策的信息科学家孙美岑（Meicen Sun）表示：“中国决定加倍努力成为该领域的全球领导者，部分归功于这些公司已经取得的成就。”但孙美岑认为，中国可能拥有的最大优势在于，中国民众，尤其是像董辉这样的患者，是……