“Our brain-computer interface (BCI) device NEO will begin large-scale clinical trials next year, with plans to recruit 30 to 50 patients for implantation in approximately 10 centers across the country,” Hong Bo, professor at Tsinghua University School of Medicine said Monday.
This means that BCI products developed in China are now close to obtaining regulatory approval for release to the market. According to Hong Bo, the participants selected for next year’s trials will be patients with spinal cord injuries. Once these implementations are completed, the clinical data will be submitted to regulatory authorities to obtain approval for the marketing of the products.
According to Chinese media Yicai, NEO was independently developed by Shanghai Neuracle Medical Technology Co, Ltd. This year, three human implantation operations were carried out, including one conducted by Huashan Hospital affiliated with Fudan University. NEO completed its development and type testing in Shanghai and in August became the first BCI product in China to enter a special examination procedure for innovative medical devices of the National Medical Products Administration.
A month ago, the hospital operated on a patient who had been paralyzed for four years following a car accident. On the third day after the operation, the patient was able to get out of bed and sit in a wheelchair. The patient can now use mental control to move his arms and perform simple actions, such as picking up a cup to drink water, according to Mao Ying, president of Huashan Hospital.
Notably, the surgery Mao performed on this patient took just over an hour, about half the time required for the previous two patients. During the procedure, a coin-sized BCI device was precisely implanted in the motor-sensory region of the brain, successfully sensing neural signals.
“Our surgery demonstrates that BCI implantation is very effective and has a high degree of standardization. I believe many centers will be able to perform such implantation procedures in the future,” he told Yicai.
Based on the characteristics of the target population, doctors believe that further development of BCI technology will help many patients with neurological impairments, including those who have suffered a stroke, to regain some basic life capabilities. For patients of different age groups, BCIs can be personalized and optimized according to their physical condition. Particularly for younger patients, early intervention and rehabilitation training should restore better quality of life and improve social abilities.
China has unveiled guidelines to support technological innovation, industrial development and security governance of future industries, including the BCI industry, according to Xinhua News Agency.
According to the report of the Chinese Academy of Information and Communication Technology on the development and application of BCI 2023, medical treatment is the predominant application field of BCI technology in China.
“Achieving efficient information transfer through remodeling of neural networks is not only essential for understanding how the brain works, but also is an important approach to developing new therapeutic methods,” said Poo Muming, an academician at the Academy. Chinese Sciences, at the BCI Society & Chen. Joint meeting of the BCI Institute.
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