An implantable brain-machine interface system for hand movement compensation developed by a Shanghai company has become the world's first invasive BMI medical device to gain market approval, marking the transition of China's invasive BMI technology from the laboratory to large-scale clinical application.

The device is expected to achieve its first clinical application in a patient this year, according to its developer, Neuracle Technology (Shanghai) Co, which was founded in 2011. The company said while ensuring quality, it will also seek to reduce manufacturing costs so that patients can access, effectively use and afford the product.

Clinical trial results showed that participants achieved significant improvement in hand-grasping ability through the device, thereby improving their quality of life, according to the National Medical Products Administration, which granted a medical device registration certificate for the product on Friday.

"We will fully support major innovations in high-end medical devices, promoting the application of new technologies, new materials, new processes and new methods in the healthcare field," the administration said. "This effort aims to enhance the international competitiveness of China's high-end medical devices while contributing to a higher quality of life for the people."

The device is designed for patients aged 18 to 60 who suffer from quadriplegia caused by cervical spinal cord injuries that leave them unable to grasp objects.

Using a coin-sized minimally invasive implant, the system extracts and analyzes brain signals in real time, enabling patients to control special gloves with their thoughts to perform actions such as grasping objects and drinking. The technology fills a gap in the global commercialization of such systems.

A core innovation of the device is its extradural implantation technique, in which electrodes are placed outside the dura mater — a thick external membrane that surrounds the brain and spinal cord. The design ensures a high signal-to-noise ratio while avoiding damage to brain tissue. Wireless power and communication allow for one-time implantation and long-term use, with surgery taking just over an hour. Patients can usually operate the system independently at home a month after surgery.

In clinical trials involving 36 participants, the device demonstrated a 100 percent improvement rate in grasping function. Some patients also showed signs of neural remodeling and recovery of additional nerve functions, according to Neuracle, one of the first domestic enterprises to focus on BMI technology.

Compared with similar technologies abroad, the product offers advantages in trauma control, patient compliance and long-term stability, addressing challenges such as high trauma and maintenance demands associated with traditional invasive techniques.

Industry experts said the product provides a Chinese solution for the treatment of neurological diseases worldwide and offers new insights for the rehabilitation of patients with nervous system disorders.

They added that BMI technology sits at the intersection of integrated circuits, biomedicine and artificial intelligence. The clinical application of the device highlights Shanghai's role as a leader in innovation in emerging industries.

Currently, about 60 BMI companies are based in Shanghai, making it one of the cities with the highest concentration of firms and the most advanced technologies in the field in China.

By 2025, Shanghai had seen three invasive products enter China's special review process for innovative medical devices, while another invasive product had entered the approval pathway for breakthrough therapies at the United States Food and Drug Administration. In addition, several noninvasive products have already been used in areas including motor function rehabilitation for stroke patients, screening for depression and anxiety, and the diagnosis and treatment of insomnia.

zhouwenting@chinadaily.com.cn