World's First Prescription! Brain-Computer Interface Enters Clinical Application at Huashan Hospital

Background

Spinal cord injuries, particularly those affecting the cervical region, frequently result in impaired hand motor function, significantly limiting patients' independence in daily activities. Conventional treatments such as medication and rehabilitation therapy often reach a plateau in restoring function for severe cases.

Brain-computer interface (BCI) technology has been under development to create direct links between brain signals and external devices, bypassing damaged neural pathways. On March 13, 2026, an implantable BCI system for hand motor function compensation received Class III medical device registration approval in China, reported as the world's first such approved implantable BCI product. Developed by Neuracle Technology (Shanghai) Co., the system known as NEO marked a step toward transitioning this technology from research and trials into clinical use.

What was achieved

On July 13, 2026, the world's first prescription for the approved implantable brain-computer interface system was issued in Shanghai. The first implantation surgery was performed at Huashan Hospital Affiliated to Fudan University. The patient had sustained a spinal cord injury in a car accident 10 years earlier, leading to impaired hand grasp function and reduced ability to live independently. Following standardized rehabilitation, functional recovery had plateaued.

Intraoperative testing confirmed that the epidural electroencephalogram (EEG) signals acquired by the system were stable and of high quality. The patient's postoperative vital signs remained stable. As the leading institution for this global first prescription and implantation, Huashan Hospital facilitated the move of the technology into real-world clinical application just four months after approval. The hospital has also launched what is described as the world's first clinical cohort study on BCIs. Clinical validation involved 32 subjects across 11 medical institutions with a 100% response rate for BCI-aided grasp function.

How it works

The NEO system is implanted during a surgical procedure, with the electrode array placed in the epidural space over the sensorimotor cortex of the brain. This placement records electrical activity without penetrating the brain tissue itself. When a patient thinks about performing a hand movement, such as grasping, the implant detects the corresponding brain signals, known as epidural EEG.

These signals are transmitted wirelessly and decoded by an external processor to interpret the user's motor intention. The decoded information then activates an external functional compensation device, typically a pneumatic glove or similar assistive apparatus worn on the hand. By translating thought into assisted physical movement, the system helps compensate for the lost natural hand function caused by the spinal cord injury, potentially improving the patient's ability to perform daily tasks like grasping objects.

What it means for international patients

With this clinical application at Huashan Hospital, eligible patients with spinal cord injuries may have access to this newly approved BCI technology as a treatment option. The hospital maintains an International Medical Center, established in 1989, which is one of the earliest in China dedicated to serving international patients. It has provided services to individuals from more than 100 countries and regions, with English-language support and specialized care pathways.

Subsequent reports indicate that the hospital has received inquiries from overseas patients interested in BCI treatment following the news of the first implantation. However, eligibility depends on specific medical criteria such as the nature of the spinal cord injury and other health factors. International patients should contact the hospital directly to undergo screening and confirm suitability for the procedure or related clinical programs.

About the hospital

Huashan Hospital Affiliated to Fudan University is located in Shanghai. Founded in 1907, it is a Class III Grade A general hospital affiliated with Fudan University. It features multiple campuses and serves as the lead unit for the National Center for Neurological Disorders.

The hospital is recognized for its expertise in neurosurgery and neurology. It is also prominent in hand surgery and other fields, with national key disciplines. Huashan Hospital's International Medical Center, established in 1989, offers dedicated services including outpatient clinics, inpatient facilities with VIP rooms, multilingual support, and coordination with international insurers.