中国批准全球首个侵入式脑机接口芯片——接下来会发生什么
TL;DR · AI 摘要
中国批准了全球首个侵入式脑机接口芯片NEO,由Neuracle Technology开发,用于治疗脊髓损伤导致的四肢瘫痪患者,该设备通过植入大脑表面收集信号并控制外骨骼手套,已进入临床应用阶段。
核心要点
- NEO是全球首个获批用于临床的侵入式脑机接口(BCI)产品,由上海Neuracle Technology公司开发。
- NEO通过在硬脑膜上放置传感器采集脑信号,经颅骨植入装置传输至计算机,控制软性机器人手套进行康复训练。
- 相比Neuralink的N1芯片,NEO设计更少侵入,风险更低,且中国监管机构为其提供了加速审批通道。
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- 全球首个侵入式脑机接口芯片NEO
- 设备研发
- Neuracle Technology
- 清华大学
- 技术原理
- 硬脑膜传感器
- 颅骨植入装置
- 软性机器人手套
- 临床应用
- 36项临床试验
- 2026年3月获批
- 适用于四肢瘫痪患者
- 监管环境
- 中国加速审批
- 对比美国FDA
金句 / Highlights
值得收藏与分享的关键句。
NEO是全球首个获批用于临床的侵入式脑机接口产品,标志着BCI技术进入实用化阶段。
NEO通过在硬脑膜上放置8个传感器采集脑信号,避免直接穿透大脑皮层,降低出血和瘢痕风险。
中国国家药监局批准NEO用于18-60岁、四肢瘫痪但手臂有残余功能的患者,比Neuralink等产品更快获得许可。
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.
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.
A world first
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.
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.
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. 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_.
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.
A big boost for BCIs
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.”
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, tend to welcome this technology and are genuinely enthusiastic about it. In comparison, in the US and Western Europe, testing technologies on human bodies elicits an “ick factor,” triggering concerns and even resistance, she says.
Cooperation in a cold climate
NEO has become the world’s first invasive BCI to go commercial, but scientists interviewed by _MIT Technology Review_ caution against comparing Chinese and US efforts through the lens of a race.
A race implies an endpoint, but it is hard to say where that is for the development of BCIs, says Nick Ramsey, a neuroscientist at Radboud University Nijmegen in the Netherlands. Also, the US and China have fundamentally different visions, Sun says. The US is primarily concerned with being the first to do something and achieving state-of-the-art performance, while winning to China means capturing more consumers and using technology to deliver solutions on a societal scale.
“Being exceptional and being accessible are two diametrically opposed definitions of winning,” Sun says.
In fact, neurotechnology has emerged as a rare tech sector where US-China collaboration is still happening despite geopolitical tensions. The US company Axoft, based in Cambridge, Massachusetts, says it has teamed up with a Chinese company and a hospital in Shanghai to test its BCI on four patients in China and has plans to expand its trials in the country.
Looking forward, China’s BCI industry is expected to speed up its growth over the next five years thanks to strong government support. “There is no comparable national-level ambition or coordinated map elsewhere in the world at the moment,” says Singh.
More BCIs are also in the pipeline for domestic approval in the country, including Beinao-1, developed by the Chinese Institute for Brain Research in Beijing and its affiliated startup, NeuCyber NeuroTech. The device, which sits on the dura mater, is designed to help those who have movement and speech difficulties due to spinal cord injuries or amyotrophic lateral sclerosis. These candidates could get the green light as early as 2028, Singh says.