美国食品和药物管理局批准全玻片成像用于初步诊断：一个关键的里程碑已经达成，同时也引发了新的问题。
US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.
机构信息
From the Laboratory Medicine Program, Department of Pathology, University Health Network, Toronto, Ontario, Canada (Dr Evans); the Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, New York (Dr Bauer); the Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida (Dr Bui); the Department of Pathology, University of Colorado Denver, Aurora (Dr Cornish); Economic and Regulatory Affairs, College of American Pathologists, Washington, DC (Ms Duncan); Affiliated Pathologists Medical Group, Rancho Dominguez, California (Dr Glassy); the Medical Brain Team, Google, San Francisco, California (Dr Hipp); Covance, Indianapolis, Indiana (Dr McGee); the Surveys Department, College of American Pathologists, Northfield, Illinois (Mr Murphy); the Department of Pathology, Emory University Hospital, Atlanta, Georgia (Dr Myers); the Department of Pathology, Manchester Memorial Hospital, Manchester, Connecticut (Dr O'Neill); the Department of Pathology, Ohio State University Wexner Medical Center, Columbus (Dr Parwani); the Department of Pathology, Dell Medical School, University of Texas at Austin (Dr Rampy); ARUP Laboratories Incorporated, Salt Lake City, Utah (Dr Salama); and the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Pantanowitz).
出版信息
Arch Pathol Lab Med. 2018 Nov;142(11):1383-1387. doi: 10.5858/arpa.2017-0496-CP. Epub 2018 Apr 30.
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.
2017 年 4 月 12 日，美国数字病理学的发展迎来了一个重要的日子，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主要诊断。虽然这一事件有望促进全切片成像在美国更广泛地应用于临床，但它也提出了一些问题，即病理学家可能会选择将这项技术纳入其临床实践的方式。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这个话题的常见问题，并根据现有信息提供了答案。
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