Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis

Digital Pathology and Whole Slide Imaging just cleared one of its toughest regulatory hurdles in the United States. On April 12, the Food and Drug Administration cleared the Philips IntelliSite Pathology Solution (PIPS) for sale in the United States. In announcing its decision, the FDA said that the Philips digital pathology product is a “whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.”