人工智能的发展对人类社会造成了巨大的影响，其应用领域覆盖包括医疗在内的各行各业。美国作为人工智能领域的领跑者，非常重视人工智能产业发展；不仅成立了专门的管理和研究机构，制定了一系列鼓励医疗人工智能发展的政策，而且对医疗人工智能产品的审批、准入和市场监管做了适应性调整，完成审批了一批以人工智能为核心技术的医疗器械软件（SaMD）。这些举措对于我国医疗人工智能发展具有借鉴意义。本文梳理了美国四年来（2016～2019）发布的（医疗）人工智能的发展政策，重点解读美国医疗器械市场准入和监管政策为了鼓励医疗器械软件（SaMD）创新而做的更新。本文对美国食品药品监督管理局（FDA）已批准上市的医疗人工智能产品做整理和归纳，介绍具有代表性的人工智能上市产品的技术优势、临床价值，为国内开展医疗人工智能产品研发提供参考。
The development of artificial intelligence has caused a huge impact on human society，and its application fields have penetrated into all walks of life including medical treatment. As a leader in the field of artificial intelligence，the United States attaches great importance to the development of the artificial intelligence industry；it has established a special management and research institution to formulate a series of policies to encourage the development of medical artificial intelligence，and does the examination，approval and market supervision of medical artificial intelligence products. After the adaptive adjustment，a batch of medical device software （SaMD） with artificial intelligence as the core technology was approved. These measures have reference significance for the development of medical artificial intelligence in my country. This article sorts out the development policy of （medical） artificial intelligence released by the United States in the past four years （2016-2019），focusing on the interpretation and revision of the US medical device market access and regulatory policies to encourage innovation in medical device software （SaMD）. This article organizes and summarizes the medical artificial intelligence products approved by the FDA，introduces the technical advantages and clinical value of representative artificial intelligence listed products，and provides references for domestic research and development of medical artificial intelligence products.
