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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].
脑机接口产业明确路线图
Jing Ji Ri Bao· 2025-10-04 22:05
Core Viewpoint - The approval of the first industry standard for brain-computer interface (BCI) medical devices in China marks a significant step towards the standardization and systematic development of the BCI industry, with a target market size of 6.14 billion yuan by 2028 [1][2]. Group 1: Policy and Standards - The National Medical Products Administration has approved the implementation of the "Terminology for Medical Devices Using Brain-Computer Interface Technology" standard, effective January 1, 2024 [1]. - The "Implementation Opinions" issued by seven departments, including the Ministry of Industry and Information Technology, aim to enhance innovation capabilities in the BCI industry and establish a reliable industrial system by 2030 [1][2]. - The establishment of a BCI technology standard system is emphasized to enhance the industry's support capabilities and promote international competitiveness [4]. Group 2: Market Potential and Applications - The BCI market in China is projected to reach 3.2 billion yuan in 2024 and grow to 6.14 billion yuan by 2028, indicating rapid industry growth [1]. - Key application areas for BCI technology include healthcare, industrial manufacturing, and consumer products, 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]. Group 3: Industry Development and Challenges - A number of innovative companies focusing on BCI technology have emerged, forming a relatively complete industrial chain, with some products already achieving medical device registration for rehabilitation [3]. - The global BCI industry faces challenges related to technology precision, industrial ecosystem strength, and ethical concerns regarding privacy and data management [3]. - Recommendations for further development include increased funding for key technology research, interdisciplinary talent cultivation, and exploration of new application scenarios [3]. Group 4: Collaborative Efforts - Strengthening collaboration among government, enterprises, and research institutions is crucial for advancing BCI technology and industry development [4]. - The need for coordinated efforts in technology research, industry growth, and safety governance is highlighted, along with the importance of local adaptation in promoting innovation [4].