중국 기업 Neuracle과 칭화대학교가 개발한 침습적 뇌-컴퓨터 인터페이스(BCI) 칩 'NEO'가 세계 최초로 임상시험을 넘어 실제 의료기기로 사용 승인을 받았습니다. 이 칩은 뇌의 보호막인 경막 위에 얇게 부착되는 방식으로 일론 머스크의 뉴럴링크보다 침습성이 낮고 안전하여 빠른 규제 통과를 이뤄냈습니다. 이를 통해 척수 손상으로 사지가 마비된 환자들이 로봇 글러브 등을 통해 일상생활을 회复하고 재활할 수 있는 길이 열렸습니다.
번역된 본문
요약: 지난 10월, 중국 허난성에 위치한 자택의 마당에 앉아 있던 동후이(Dong Hui)는 자신이 펜을 잡고 글씨를 쓸 수 있을지 시도해 보기로 했다. 39세의 동은 6년 전 교통사고로 척수를 다쳐 목 아래가 전신 마비 상태가 되었다. 천천히 하지만 확고한 의지로 그는 자신의 이름, '고맙습니다', 그리고 날짜를 적었다. 이는 그의 뇌에 이식된 칩 덕분에 가능했던 11개월간의 재활 치료의 결과였다. 그 과정 이전에도 동은 팔을 약간 움직일 수는 있었지만 손가락을 사용할 수는 없었다. "다시 글씨를 쓸 수 있다는 것을 믿을 수 없었습니다. 너무 흥분해서 이름을 쓸 때 획 하나를 빼먹기까지 했어요"라고 그는 영상 통화에서 MIT 테크놀로지 리뷰에 말했다. 2024년 11월, 동은 뇌 수술을 통해 중국에서 최초로 침습적 뇌-컴퓨터 인터페이스(BCI)를 이식받은 사람 중 한 명이 되었다. 그는 TV에서 BCI가 다른 전신 마비 중국인 남성이 손녀를 안을 수 있게 해주는 것을 본 지 한 달 후, 이 기기 개발사의 임상시험에 자원했다. 올해 3월, 동이 사용하는 이식 장치는 임상시험을 넘어 사용 승인을 받은 세계 최초의 침습적 BCI 제품이 되었다. 이 제품은 현재 척수 손상으로 인해 사지 마비를 겪는 일부 환자에게 제공되고 있다. 우리는 이 기기가 어떻게 이 글로벌 이정표에 도달할 수 있었는지, 이 순간이 왜 그토록 중요한지, 그리고 앞으로 무엇을 기대할 수 있는지 이해하기 위해 다양한 전문가들과 이야기를 나누었다.
세계 최초의 기록
동의 뇌 이식물은 'NEO'라 불리는 동전 크기의 장치다. 이는 상하이에 본사를 둔 스타트업 Neuracle Technology(뉴러클 테크놀로지)가 베이징의 칭화대학교 연구진과 함께 개발했다. 1시간 반 남짓 걸린 수술 동안, 동의 뇌 신호를 수집하는 이 기기의 센서는 뇌를 덮고 보호하는 단단한 외부 조직층인 경막(dura mater) 위에 배치되었다. 이 신호는 동의 두개골에 이식된 장치를 통해 컴퓨터로 전송된다. 그러면 컴퓨터는 그 신호를 동이 매일 완료하는 2.5시간의 훈련 세션에서 착용하는 부드러운 로봇 글러브에 대한 명령으로 변환하여, 그가 물건을 잡는 법을 배우도록 돕는다. 동은 수술 후 약 일주일 후에 재활을 시작했다. "훈련 9일 차에 글러브 없이도 내 오른손이 공을 성공적으로 잡았습니다. 그것은 기적 같은 순간이었어요"라고 그는 말한다. 지금도 그는 집에서 계속 훈련을 이어가고 있다. 그는 늙어가는 부모님에게 부담을 주지 않고 옷을 입고, 식사하고, 다른 일상적인 작업들을 수행하기 위해 손을 더 잘 제어할 수 있기를 원한다.
NEO의 최근 승인 덕분에 중국 내 점점 더 많은 외상성 부상 환자들이 비슷한 길을 걷게 될 것이다. 의약품 감시를 담당하는 국가의약품감독관리국에 따르면, 이 제품은 척수 손상으로 인해 사지 전체가 마비되었지만 팔에 약간의 잔여 기능이 남아있는 18세에서 60세 사이의 환자에게 적합하다. NEO는 일론 머스크가 설립한 캘리포니아 기반 기업 뉴럴링크(Neuralink) 등 여러 다른 BCI 기기를 제치고 승인을 받았다. 2023년 10월 이후, Neuracle은 동의 사례를 포함하여 NEO를 이용한 36건의 임상시험을 진행했다. 그중 32건은 2025년 불과 몇 달 사이에 이루어졌으며, 초기 대면 시험 4건 중 1건에 대한 세부 정보는 작년 7월 프리프린트 논문으로 발표되었다. Neuracle은 MIT 테크놀로지 리뷰의 코멘트 요청에 응답하지 않았다.
시드니 공과대학교의 BCI 연구원인 아비나시 싱(Avinash Singh)에 따르면, NEO가 빠르게 승인을 받은 이유 중 하나는 뉴럴링크의 N1 뇌 칩과 같은 경쟁 제품들보다 '비교적 덜 침습적인' 설계를 갖추고 있기 때문이다. NEO의 8개 센서는 뇌의 보호막 위에 놓이는 반면, 뉴럴링크의 N1 칩은 뇌의 가장 바깥층인 대뇌피질을 직접 관통한다. 싱은 Neuracle의 기기가 출혈, 신경교세포 반흔(글리아 흉터), 장기적인 신호 저하의 위험이 낮기 때문에 직면하는 규제 제한이 더 적다고 말한다. 또한 중국 내 BCI 산업에 대한 강력한 정부 지원 덕분에 NEO는 신속한 규제 승인 경로에 올랐다.
EXECUTIVE SUMMARY 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. 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