我国首部脑机接口医疗器械标准明年1月1日正式实施
Jing Ji Ri Bao·2025-10-05 01:11

Core Viewpoint - The implementation of China's first brain-computer interface (BCI) medical device standard on January 1, 2024, marks a significant step towards the development of a standardized and systematic BCI industry, aiming to enhance innovation capabilities and establish a competitive ecosystem by 2030 [1][2]. Group 1: Industry Development - The newly approved standard, titled "Terminology for Medical Devices Using Brain-Computer Interface Technology," is expected to drive the BCI industry towards a more organized and standardized framework [1]. - By 2024, the Chinese BCI market is projected to reach 3.2 billion yuan, with expectations to grow to 6.14 billion yuan by 2028 [1]. - The "Opinions" document outlines six key tasks and 17 specific measures to promote the BCI industry, enhancing its international competitiveness and facilitating applications across various fields [2]. Group 2: Applications and Innovations - The primary applications of BCI technology are in healthcare, industrial manufacturing, and consumer life, with significant potential for integration with AI, digital biology, and augmented reality [2]. - In healthcare, BCI can be utilized for diagnosing and rehabilitating neurological diseases such as epilepsy, Parkinson's, and Alzheimer's [2]. - The industrial sector can benefit from improved control of robots and enhanced safety and efficiency in high-risk industries like nuclear energy and mining [2]. Group 3: Challenges and Recommendations - The global BCI industry faces challenges related to technology precision, industry ecosystem strength, and ethical concerns regarding privacy and data management [3]. - Recommendations for advancing the BCI industry include increased funding for key technology research, interdisciplinary collaboration, and the cultivation of specialized talent [3]. - The establishment of a comprehensive standard system for BCI technology is crucial for enhancing industry support capabilities and facilitating international standard participation [4].