A Tianjin University-led project has completed the first clinical research filing for a noninvasive brain-computer interface (BCI) under China's new biomedical regulations, giving researchers a formal route to test the technology in patients as Chinese companies seek to develop commercial applications.
The filing was completed with the National Health Commission on Nov 5, the university said.
The system combines a noninvasive BCI, spinal cord stimulation and a powered exoskeleton to help stroke patients regain movement in their legs. Developed by the university's Haihe Laboratory of Brain-Computer Interaction and Human-Machine Integration, it detects brain signals associated with a patient's intention to move, then coordinates electrical stimulation and the exoskeleton to assist walking.
Researchers aim to help patients recover motor function, rather than rely solely on mechanical assistance. The study will examine safety and feasibility in people whose recovery has stalled after conventional rehabilitation. Its clinical benefits have yet to be established.
The filing does not amount to approval for commercial use. It comes after regulations governing clinical research and the application of new biomedical technologies took effect in May. The rules require scientific and ethical reviews and set out procedures for testing experimental treatments in patients.
Ming Dong, vice-president of Tianjin University and director of the laboratory, said researchers would follow the filed study protocol and refine rehabilitation plans for individual patients.
Hao Fei, a lecturer at the International Business School of the University of International Business and Economics, said the filing was significant because it brought the technology into a more standardized clinical research process.
China is also pursuing implantable BCI technology. In March, the National Medical Products Administration approved a device developed by Shanghai-based Neuracle Technology that helps people with paralysis caused by cervical spinal cord injuries grasp objects using an assistive glove.
Implantable systems can capture clearer neural signals but require surgery. Noninvasive devices typically use sensors placed on the scalp, making them easier to deploy, although the signals can be harder to interpret.
Brokerage China Securities said in a research note that the global BCI industry remains at an early stage, leaving room for Chinese developers to benefit from the country's engineering workforce and manufacturing supply chains. It compared the potential for growth with China's development of electric vehicles and innovative medicines.
The BCI sector was designated a future industry in this year's Government Work Report. It was also included in the outline of the 15th Five-Year Plan (2026-30) as the country aims to cultivate it into a new engine of growth.
Guidelines issued by seven central government departments in 2025 called for breakthroughs in key BCI technologies by 2027 and globally competitive companies to emerge by 2030. They also set out measures to improve standards and promote the development of practical products.
China had more than 200 BCI-related companies, according to a report released in August 2025 by the China Academy of Information and Communications Technology and the Brain-Computer Interface Industry Alliance. The academy projected that China's BCI market could reach 10 billion yuan ($1.5 billion) to 14 billion yuan by 2030.
Hao cautioned that noninvasive devices would not necessarily capture a larger market simply because they were easier to use. He said implantable and noninvasive systems could develop for different medical needs.
"The market prospects for both approaches depend not only on technological breakthroughs but also on the use of data and the development of the innovation ecosystem," he said.
Neural data are sensitive and often held by separate institutions. Hao said protecting privacy while allowing high-quality data to be shared lawfully, and strengthening cooperation among hospitals, universities and companies, would be important in turning research into treatments patients can use.
