Royal Philips announced on Wednesday that the FDA cleared its Philips IntelliSite Pathology Solution (PIPS) for primary diagnostic use.
It's the first whole-slide imaging system that can be used to review and interpret digital surgical pathology slide prepared from biopsied tissue.
"[PIPS] allows pathologists to simplify access to histopathology information and work more efficiently," Russ Granzow, general manager of Philips Digital Pathology Solution, told HCB News. "The pathologists will have the agility to view digital images and aim to extend collaboration with peers, with the aim of increasing diagnostic confidence."
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As cancer becomes more prevalent, pathologists are under pressure to meet the demand. They have to work as efficiently and effectively as possible to analyze the complex data that's used to design personalized treatments.
PIPS is composed of an ultra-fast pathology slide scanner, an image management system and display monitor. It also comes with advanced software tools to manage the scanning, storage, presentation, reviewing and information sharing processes.
With this solution, pathologists can read tissue slides digitally to make a diagnosis, instead of using a conventional light microscope to look directly at the tissue sample mounted on a glass slide.
"Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other health care professionals and patients faster," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement.
The agency evaluated data from a clinical study that involved about 2,000 surgical pathology cases. It was one of the largest studies that directly compared the use of digital pathology to conventional optical microscopes.
Sixteen pathologists at Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates performed about 16,000 reads of the cases. The results showed that the diagnoses made using PIPS were comparable to those made using the conventional method.
Previously, PIPS was only approved by the FDA to be used as an aid to the pathologist when detecting HER2 expression in breast cancer.
It's now been expanded for primary diagnostic use.
Digital pathology has been a major focus for Philips in recent years. In June 2016, the company acquired PathXL's digital pathology portfolio.
More recently in March, they partnered with
a developer of artificial intelligence technology for pathology called PathAI.
In the same month, Philips introduced new additions to its pathology solutions portfolio at the 2017 United States and Canadian Academy of Pathology Annual Meeting. That includes research applications called TissueMark and Xplore, and applications for semi-quantification of breast IHC markers.