According to the website of the National Medical Products Administration, it has recently approved the registration application for the innovative product of Borui Kang Medical Technology (Shanghai) Co., Ltd.'s implantable brain computer interface hand motion compensation system, achieving the global first launch of brain computer interface medical devices and marking the international first invasive brain computer interface medical device entering the clinical application stage. This product consists of a brain computer interface implant, an implanted EEG electrode kit, an EEG signal transceiver, pneumatic glove equipment, a disposable surgical kit, EEG coding software, medical testing software, and clinical management software. Suitable for patients with quadriplegia caused by cervical spinal cord injury, using pneumatic glove equipment to assist in compensating for hand grasping function. The patient must meet the following conditions: be between 18 and 60 years old, have quadriplegia with a C2 to C6 cervical spinal cord injury rating of A to C, have been diagnosed with the disease for more than 1 year and have been stable for at least 6 months after standardized treatment, have difficulty grasping the hand, and still have partial upper arm function. This product adopts minimally invasive implantation outside the dura mater and wireless power communication technology. Clinical trial results show that subjects have significantly improved their hand grasping ability through this product, thereby improving their quality of life. In recent years, the National Medical Products Administration has resolutely implemented the major decisions and deployments of the Party Central Committee and the State Council on improving the mechanism for supporting the development of innovative medical devices, issued detailed measures, strengthened departmental coordination, encouraged medical engineering integration and scientific research transformation, fully supported major innovations in high-end medical devices, and promoted the application of more new technologies, materials, processes, and methods in the field of medical health. As a future industry identified in the "15th Five Year Plan" outline, brain computer interfaces are highly valued by the National Medical Products Administration. In the product evaluation and approval process, resources are tilted, and in accordance with the principles of "early intervention, one enterprise, one policy, full process guidance, and research review linkage", pre evaluation services are provided for innovative products, effectively accelerating the product launch process and effectively enhancing the international competitiveness of China's high-end medical devices. Next, the National Medical Products Administration will continue to do a good job in the evaluation and approval of high-end medical devices, effectively using efficient supervision to support the high-quality development of the medical device industry and benefit the people's high-quality life. The drug regulatory authorities will strengthen post market supervision of the product to protect the safety of patients using the device. (New Society)
Edit:WENWEN Responsible editor:LINXUAN
Source:people.com
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