US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis A Key Milestone Is Reached and New Questions Are Raised
US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis A Key Milestone Is Reached and New Questions Are Raised
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DOI：
10.5858/arpa.2017-0496-cp
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发表时间：
2018-11-01
影响因子：
4.6
通讯作者：
Pantanowitz, Liron
中科院分区：
文献类型：
--
作者：
Evans, Andrew J.;Bauer, Thomas W.;Pantanowitz, Liron
2017年4月12日标志着美国数字病理学发展的重要一天，美国食品和药物管理局宣布批准飞利浦IntelliSite病理解决方案用于外科病理学的初级诊断。虽然这一活动有望促进全玻片成像在美国临床应用中的更广泛应用，但它也提出了一些问题，即病理学家可能选择将这项技术应用于临床实践的方法。这篇来自美国病理学家学院数字病理学委员会的文章回顾了关于这个主题的常见问题，并根据目前可用的信息提供了答案。
April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.