Shanghai Step Medical Advances First Chinese Implantable Wireless Brain-Computer Interface into National Innovation Review Pathway

Our Staff Reporter (Gao Yang) Recently, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) announcedInnovative HealthcareIn the public notice list of the special review results for medical device applications, the "Implantable Wireless Brain-Computer Interface System" applied for by Shanghai StairMed Technology Co., Ltd. has officially entered the "Special Review Procedure for Innovative Medical Devices" (also known as the "Innovation Green Channel"). This is also the first implantable brain-computer interface product in China to enter the National Medical Products Administration's special review process for innovative products.

Reporters learned that the "Innovation Green Channel" is a priority review process established by the National Medical Products Administration (NMPA) to encourage medical device innovation. It focuses on technological leadership and supports the domestic production of high-end medical devices in China. The "system-level products" entering the "Innovation Green Channel" this time require companies to overcome multi-disciplinary technical barriers and meet the extremely high requirements of regulatory authorities for the safety, effectiveness, and reliability of the entire system.

A relevant official from StairMed stated that the entry of this product into the innovative special review process signifies that the implantable brain-computer interface has not only achieved clinical validation in terms of technology, but also clarified its industrialization and compliance registration pathway, forming a complete positive cycle of "technological breakthrough – clinical validation – registration and market launch."

Going forward, the company will continue to advance the safety verification and large-scale application of its products, enabling brain-computer interface technology to be more widely applied in areas such as motor language function replacement, neurological disease treatment, and sensory restoration.

In March this year, based on its self-developed implantable brain-computer interface system, StairMed successfully completed the first-in-human (FIM) clinical trial for the long-term implantation of an implantable brain-computer interface system in China at Huashan Hospital Affiliated with Fudan University. This achievement marks that China has become the second country in the world to enter the clinical trial stage for implantable brain-computer interface technology.