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基于脑机接口技术的医疗器械
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国家药监局:将助力基于脑机接口技术的医疗器械产品在中国早日上市
news flash· 2025-07-14 10:45
Group 1 - The core viewpoint is that brain-computer interface technology is a cutting-edge development direction globally, with Beijing making significant progress in the innovation and transformation of medical devices based on this technology [1] - The National Medical Products Administration (NMPA) will continue to closely monitor the research and development progress of medical devices in the brain-computer interface field [1] - The NMPA plans to collaborate with relevant departments to introduce supportive measures and provide targeted solutions to facilitate the market launch of brain-computer interface-based medical devices in China [1]
政策支持高端医疗器械创新发展 企业、患者和产业将迎来这些利好
Yang Shi Xin Wen· 2025-07-11 08:01
国家药监局日前发布十条举措,大力支持我国高端医疗器械创新发展。那么,最新出台的新政策,主要 聚焦哪些高端医疗器械?有哪些是国内首创或是国际领先的措施?我国高端医疗器械企业、患者和产业 将迎来哪些利好?本台记者独家采访国家药监局相关业务的负责人进行解读。 我国出台新政助推高端医疗器械万亿市场 国家药监局医疗器械注册司司长吕玲:这次的支持举措我们重点选取了医用机器人、高端医学影像设 备、新型生物材料医疗器械、人工智能医疗器械,因为它们就是高端医疗器械的典型代表性产品,也是 塑造医疗器械新质生产力的关键领域,也充分代表着当前医疗器械行业发展的方向。 国家药监局表示,当前出台这些重磅措施支持高端医疗器械发展,希望促进更多新技术、新材料、新工 艺和新方法应用于医疗健康领域。 国家药监局医疗器械注册司司长吕玲:比如基于脑机接口技术的医疗器械,还有腹腔内窥镜手术系统, 还有多病种大模型的人工智能医疗器械等等,这些都是我们目前聚焦的重点产品,我们就是要通过以点 带面,通过大力支持这些代表性的产品来努力抢占国际制高点,使得更多"中国造、全球新"的医疗器械 早日上市。 国家药监局医疗器械注册司司长吕玲:比如产品上市前我们将审评的 ...
美国取消对中国芯片设计软件的出口限制;我国成功发射试验二十八号B星01星丨数智早参
Mei Ri Jing Ji Xin Wen· 2025-07-03 23:24
Group 1 - China's successful launch of the experimental satellite Tiankong-28B01 demonstrates the country's solid development in space technology, with the Long March 4B rocket completing its 583rd flight [1] - The satellite is primarily used for space environment detection and related technology experiments, reinforcing China's capability in autonomous space technology [1] Group 2 - Siemens announced that the U.S. government has lifted export restrictions on chip design software to China, allowing full access for Chinese customers to Siemens' software and technology [2] - This change indicates a potential easing of trade tensions and could enhance collaboration in the technology sector between the U.S. and China [2] Group 3 - The National Medical Products Administration of China is implementing supportive policies for high-end medical devices based on brain-computer interface technology, aiming to optimize the innovation review process [3] - The initiative includes special reviews for innovative medical devices with significant clinical value, enhancing communication between applicants and review experts [3] - The regulatory framework aims to accelerate the market entry of high-end medical devices, ultimately improving accessibility to advanced medical technologies for patients [3]