Breakthrough in Neurotechnology: World's First Approved Implantable Brain-Computer Interface Enables Paralyzed Patients to Control Devices by Thought

Today,Neuracle Technology (Shanghai) Co., Ltd.'s implantable brain-computer interface hand motor function compensation system has officially obtained China's Class III medical device registration certificate, becoming the world's first approved and marketed implantable brain-computer interface Class III medical device.According to reports,Expected to achieve the clinical application for the first patient within this year.

This product is suitable for ages 18 to 60.Patients with cervical spinal cord injuries leading to quadriplegia and inability to grasp with their fingers, throughCoin-sized minimally invasive implant, real-time extraction and analysis of EEG signals,Help patients control pneumatic gloves with brain intentions to complete actions such as grasping and drinking., filling the industrialization gap in related fields globally.

Its core innovation lies in the adoption of epidural implantation technology, with electrodes sutured outside the dura mater, ensuring a high signal-to-noise ratio for signal acquisition while avoiding damage to brain tissue. Its wireless power supply and communication design achieve "once implanted, long-term usability."The surgery takes only a little over an hour, and the patient can operate independently at home one month after the surgery.Data from 36 clinical trials (4 feasibility clinical trials, 32 multi-center registration clinical trials) show,The improvement rate of patients' grip function reached 100%, and some patients showed signs of neural remodeling, with additional recovery of partial neurological functions.Compared with similar technologies abroad, this product has significant advantages in trauma control, patient compliance, and long-term stability, solving the pain points of traditional invasive technologies, such as large trauma and the need for maintenance by professional teams.

The product has been approved.Marks the transition of China's brain-computer interface technology from laboratory to scaled clinical application., providing a "Chinese solution" for the treatment of neurological diseases globally. As an intersection area of the three leading industries—integrated circuits, biomedicine, and artificial intelligence—its industrial implementation not only highlights Shanghai's innovative leadership in future industries but will also drive the coordinated development of upstream and downstream materials, chips, precision manufacturing, and other related industrial chains, bringing rehabilitation hope to more patients with neurological disorders.

40-Year-Old Man Experiences Significant Changes After Surgery!

Huashan Hospital President: "Absolutely Surprised"

Huashan Hospital has completed the national multi-center clinical trial research on 32 subjects, including Xiao Dong, and conducted a six-month neurological function rehabilitation observation on them, with encouraging results.The 32 patients enrolled in the clinical trial had all lost hand function due to high cervical spinal cord injury. After an average rehabilitation plateau period of three to four years, their hand function had more or less shown autonomous recovery.

At the age of 40, Xiaodong suffered a misfortune six years ago: a car accident caused damage to his cervical spinal cord, leaving him unable to grasp with his hands or stand. On November 6, 2024, his life took a complete turn thanks to technology. At the Hongqiao branch of Huashan Hospital Affiliated with Fudan University, a significant brain-computer interface surgery was successfully completed. After continuous follow-up rehabilitation post-surgery, a surprising development occurred one month later: with the assistance of an air-filled glove, he was able to lift a cup smoothly and even drank water by holding the cup himself.

At that time, this scene shocked everyone present. Another two years passed, and Xiaodong's recovery reached a new level:Taking off the balloon gloves, he used his left hand to support his right hand and autonomously wrote the two characters "Xiao Dong" for the first time. The miracle of life once again "amazed" everyone. Xiao Dong then made an effort to write "thank you" to express gratitude for the miracles of life and technology he has encountered over the years.

"I remember two patients who, without carrying brain-computer interface devices, experienced a significant leap in recovery after extensive training."Mao Ying, Dean of Huashan Hospital and Chief of Neurosurgery, Leading Clinical TrialsSay. Take Xiaodong as an example. After getting through the rehabilitation period on the platform, he was able to write with his left hand supporting his right hand without any mechanical device. "This is not an accidental phenomenon; it indicates that the human brain has its circuits. Intensive training after installing a brain-computer interface will form those circuits." Although such understanding is not completely unexpected for neurosurgeons, seeing it actually happen in patients is still quite exhilarating.

Mao YingThe professor said directly in an interview with the Liberation Daily·Shanghai Observer:"The changes brought by brain-computer interface in recent years have been so tremendous that I am often pleasantly surprised beyond expectation. It has opened a crack of the door for us. We know there is light inside. Along this path, we can regain the lost functions of the brain!"

“The Core Value of Brain-Computer Interface Lies in Meeting Clinical Needs, Not Showing Off Skills”

Neuracle founder Xu Honglai's first and most profound impression of brain-computer interfaces was set during his freshman year when he entered the neuroengineering lab at Tsinghua University: a teacher had deliberately shaved his head to facilitate brain-computer interface research. The lab was almost entirely equipped with imported devices, and even the initial experimental data came from abroad.

These images became the original intention of his later entrepreneurship. In 2011, when Neuracle was founded, it focused on the底层研发与产业化 of brain-computer interface technology and was one of the earliest companies in China to concentrate on brain-computer interface technology. They spent five years developing the brain electrical signal acquisition module with the fastest communication rate in the world, creating an independently controllable tool for brain science research in China.

At that time, non-invasive brain-computer interface products had been implemented in multiple hospitals. Neuracle stood at a critical crossroads: to follow the well-trodden path or to venture into uncharted technological territory? Non-invasive technology, with electrodes placed outside the skull, has always been constrained by physical limitations in signal acquisition. Could they go deeper—by bringing electrodes into the skull?After gaining insight into the real needs of patients, Neuracle firmly committed to the development of epidural implants and reached a consensus: the core value of brain-computer interfaces lies in addressing clinical needs, not in showcasing technical prowess.

"Exploring the 'unmanned area' is more difficult than imagined. The biocompatibility of electrode materials, the long-term stability of implants, and the minimization of surgical trauma—each challenge has no established experience to follow, and every breakthrough pushes the boundaries of technology."

Clinical trials are indeed a real "tough battle". In October 2023, the NEO product completed its first implantation at Xuanwu Hospital, Capital Medical University; in August 2024, the product entered the National Medical Products Administration.Innovative HealthcareSpecial Review Channel for Devices; Starting May 2025, a multi-center registration clinical trial will be launched in 11 hospitals across China, setting an industry record of completing 32 clinical trials in 78 days.

The pricing for the implant surgery has not been clearly defined.

Strict evaluation is required for promotion and application.

The World's First Implantable Brain-Computer Interface Class III Medical Device Approved for Marketing, Brain-Computer Interface Implants to Welcome Another Wave of Enthusiasm. Reporters learned that the pricing for related implantation surgeries has not been clearly defined yet, and experts have simultaneously pointed out:In the face of new technology promotion and encouragement of innovation, a rigorous and cautious attitude must also be maintained.

"Brain-computer interface is by no means as simple as 'snapping one's fingers.' The general public should not assume that after having a brain-computer interface installed, all functions will be restored the next day after surgery, or even that paralyzed individuals will be walking briskly," Mao Ying clarified."From the perspective of the existing 32 clinical trial cases, every small step of recovery is inseparable from the patients' exceptionally diligent training."

The reporter learned that currently, brain-computer interface implant surgeries are being conducted at large national medical centers such as Huashan Hospital. Preoperative evaluations and case selections must strictly conform to relevant indications. Experts added that the launch of every product in the medical field requires rigorous clinical trial research, and the medical institutions performing the procedures should also meet stringent criteria.

Brain-computer interfaces need to strictly adhere to "ethical standards".Currently, the medical institutions conducting implant surgeries are all research hospitals that meet the national GCP standards. Taking Huashan Hospital as an example, before conducting implant surgeries, the hospital undergoes two rounds of medical ethics and safety evaluations, along with an additional assessment by the relevant academic committee in Shanghai, to ultimately ensure that the new technology brings therapeutic hope to patients without causing any other harm to the body.

This clinical trial led by Huashan Hospital is considered the world's first attempt in the field of brain-computer interface implant surgery, and the related work has also provided a Standard Operating Procedure (SOP) for subsequent efforts, ensuring that the new technology advances more steadily, quickly, and effectively.

This article is compiled from: Shanghai Observer

Relevant Authors: Huang Haihua, Gu Yong, Yu Minzhi

WeChat Editor: Rong