Philips Submits Study to FDA

Royal Philips has completed their controlled multicenter pivotal validation study. This study compares pathologists that use digital whole slide imaging as compared to traditional optical diagnoses done through a microscope. The study which examined the diagnosing of surgical pathology tissue slides from a range of tissues met the pre-specified endpoint.

This study is one of the largest studies to directly compare the use of digital pathology to optical microscopes. The four clinical study sites included the Cleveland Clinic, University of Virginia, Miraca Life Sciences, and Advanced Pathology Associates with 16 pathologists conducting the research.

Philips IntelliSite digital solution is an open platform integrating ultra-fast slide scanners, an image management system, and a web-based pathology viewer

In the U.S., the Philips  digital pathology solution is presently cleared as an aid to the pathologist to use to detect HER2 which is used as an important biomarker and a therapy for about 30 percent of breast cancer patients.

The newly completed clinical validation study by Philips will be submitted to FDA along with other data and information in support of a de novo submission and then if cleared by FDA would expand for the use of the Philips digital pathology solution.

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