US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised. Arch Pathol Lab Med 2018 Nov;142(11):1383-1387
Date
05/01/2018Pubmed ID
29708429DOI
10.5858/arpa.2017-0496-CPScopus ID
2-s2.0-85055277503 (requires institutional sign-in at Scopus site) 118 CitationsAbstract
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.
Author List
Evans AJ, Bauer TW, Bui MM, Cornish TC, Duncan H, Glassy EF, Hipp J, McGee RS, Murphy D, Myers C, O'Neill DG, Parwani AV, Rampy BA, Salama ME, Pantanowitz LAuthor
Toby Charles Cornish MD, PhD Professor in the Pathology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
HumansImage Interpretation, Computer-Assisted
Pathology, Surgical
United States
United States Food and Drug Administration
