我国首个脑机接口医疗器械标准实施 脑机接口，加快接入现实生活（瞰前沿）

Core Viewpoint - The implementation of China's first medical device standard for brain-computer interface (BCI) technology marks a significant step towards integrating advanced technologies into healthcare, aiming to enhance patient rehabilitation and treatment options [1][2]. Group 1: Standard Definition and Significance - The newly established standard defines "medical devices using brain-computer interface technology" as devices that decode neural signals from the central nervous system to facilitate real-time interaction between patients and external devices, improving or replacing certain physiological functions [3]. - The standard aims to unify terminology across various disciplines involved in BCI technology, addressing inconsistencies that hinder industry development and providing a clear technical basis for regulatory oversight [4]. - Establishing this standard is expected to create a unified language system for the emerging BCI field, enhancing collaboration across disciplines, improving product development efficiency, and setting benchmarks for market competition [4]. Group 2: Potential and Future Directions - BCI medical devices represent a revolutionary advancement in healthcare, with the potential to restore bodily functions for patients with conditions like spinal cord injuries, enabling them to control robotic arms or communicate through thought [5]. - The National Medical Products Administration plans to promote innovation in BCI medical devices through regulatory measures and scientific research, facilitating the transition from concept to clinical application [5]. - Clinical trials at institutions like Beijing Tiantan Hospital demonstrate the practical applications of BCI technology, with patients undergoing rehabilitation training showing significant improvements in motor functions [7][8]. Group 3: Technological Advancements and Applications - Recent clinical trials have showcased the ability of high-level paraplegic patients to control electric wheelchairs and robotic dogs using implanted BCI devices, expanding the scope of traditional medical applications [9]. - The development of advanced neural data compression techniques and low-latency control systems is crucial for ensuring effective interaction between patients and external devices, enhancing the user experience [10][11]. - The integration of BCI technology with smart devices like robotic arms and electric wheelchairs is essential for improving the quality of life for patients, highlighting the importance of external device development in realizing the full potential of BCI systems [11].