Global First Approval for Invasive Brain-Computer Interface Achieved in Shanghai: Full Industrial Chain Model Unveiled

Source: @First_Finance_Daily Weibo

【#The World's First Brain-Computer Interface Approval is Here#！An In-Depth Look at How the Shanghai Model Powers Through the Entire Industry Chain 】#The Person in Charge Says It’s Also Important to Make Brain-Computer Interfaces Affordable for Patients# On the 13th, the official website of the National Medical Products Administration announced that recently, the National Medical Products Administration approved the innovative product registration application of Neuracle Technology (Shanghai) Co., Ltd. for its implantable brain-computer interface hand motor function compensation system, marking the world’s first launch of a brain-computer interface medical device. This signifies that the world’s first invasive brain-computer interface medical device has entered the clinical application stage.

Since entering clinical trials in 2023, Neuracle's products have been implanted in a total of 36 patients with cervical spinal cord injury and paralysis by Huashan Hospital Affiliated to Fudan University, Xuanwu Hospital of Capital Medical University, and other clinical trial centers. Among them, four cases were pre-clinical and 32 cases were multi-center clinical trials. All patients successfully achieved home-based brain-controlled grasping assistance and rehabilitation training, meeting the primary clinical endpoint with 100% success, without any serious device-related adverse events reported. This has preliminarily verified the safety and long-term feasibility of the epidural minimally invasive implantation approach.

"Obtaining the certification is just the beginning. Subsequent efforts will focus on accelerating the product's adoption in hospitals, establishing standardized usage and rehabilitation procedures, and striving to achieve the first clinical application for a patient within the year. Meanwhile, continuous optimization of the product manufacturing process will be carried out to ensure stable large-scale production, improve the supply chain, and reduce manufacturing costs while guaranteeing quality. This way, patients will not only have access to the product but also be able to use it effectively and affordably," said a relevant official from the Shanghai Science and Technology Commission.