- PR Newswire•yesterdayMulti-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.
AMSTERDAM, Oct. 21, 2016 /PRNewswire/ -- Royal Philips (NYSE: PHG, AEX: PHIA) today announced the successful completion of its well-controlled, multicenter pivotal validation study designed to compare diagnoses determined by pathologists from digital whole slide imaging to traditional optical diagnoses through a microscope. In the U.S., the Philips IntelliSite Digital Pathology Solution is presently cleared as an aid to the pathologist in the detection of HER2/neu. "Philips is committed to working alongside regulators and pathologists to better understand and evaluate the clinical validity of this technology," said Russell Granzow, General Manager, Philips Digital Pathology Solutions.
Koninklijke Philips N.V. (PHG)
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