National Medical Products Administration: The first invasive brain-computer interface medical device has been approved for market launch.

Recently, the National Medical Products Administration approved the registration application for the innovative product of the Brain-Machine Interface hand movement compensation system by BoruiKang Medical Technology (Shanghai) Co., Ltd., marking the global first launch of invasive Brain-Machine Interface medical devices, signaling the entry of the world's first invasive Brain-Machine Interface medical device into clinical application. The product consists of a brain-machine interface implant, implantable brain EEG electrode kit, EEG signal transceiver, pneumatic glove device, disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia due to cervical spinal cord injury, assisting in the compensatory grasp function of the hand through the pneumatic glove device. Patients must meet the following conditions: aged 18 to 60, quadriplegia of grades A to C due to C2~C6 cervical spinal cord injury, disease diagnosed for more than 1 year with stable condition for at least 6 months after standardized treatment, inability to grasp with the hands, and partial functionality remaining in the upper arms. The product uses minimally invasive implantation of the dura mater and wireless power supply communication technology. Clinical trial results show that subjects achieved a significant improvement in hand grasping ability through this product, thereby improving the quality of life for patients. In recent years, the National Medical Products Administration has resolutely implemented the major decisions on improving and supporting the development mechanism of Innovative Medical Management devices by the Central Committee of the Communist Party of China and the State Council, issuing detailed measures, strengthening departmental coordination, encouraging the integration of medicine and engineering, and promoting the application of new technologies, materials, processes, and methods in the field of medical health. As Brain-Machine Interface is identified as an industry in the "Thirteenth Five-Year Plan," the National Medical Products Administration attaches great importance to it, tilting resources in product review and approval, conducting pre-review services for innovative products, accelerating the process of product launch, and effectively enhancing the international competitiveness of high-end medical devices in China. In the next step, the National Medical Products Administration will continue to do a good job in the review and approval of high-end medical devices, effectively assisting in the high-quality development of the medical device industry with efficient supervision, benefiting the people with a high-quality life. The drug regulatory authority will strengthen post-market supervision of the product to ensure the safety of patient use. This article is selected from the official website of the National Medical Products Administration, edited by GMTEight: Feng Qiuyi.