【全球首个人工智能+脑机接口标准在我国发布】国家药监局今天批准发布我国第三个脑机接口医疗器械标准，也是全球第一个采用人工智能技术处理脑电数据的脑机接口医疗器械产品标准，新标准将于明年9月1日起正式实施。据了解，新标准系统规范了脑机接口医疗器械的数据采集、处理、标注、存储和访问等全流程的技术要求和测试方法，帮助企业破解脑机接口医疗器械在数据集质量控制尺度不统一、建设过程不规范等共性问题。国家药监局表示，脑机接口医疗器械，就像一台能“读懂”大脑信号的智能机器，它需要通过“学习”大量脑电数据、“训练”人工智能算法，才能准确理解患者的意图。这不仅关系到治疗效果，而且和患者的安全风险息息相关。为了支持我国脑机接口医疗器械重大创新，满足产业发展急需，国家药监局采用快速程序立项和批准，新标准为脑机接口医疗器械的研发生产提供了统一的脑电数据集的“质量标尺”，达到国际领先水平。
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