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.

Arch Pathol Lab Med. 2018 Apr 30;:

Authors: 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 L

Abstract
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.

PMID: 29708429 [PubMed - as supplied by publisher]

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