NEW YORK (360Dx) – The US Food and Drug Administration on Wednesday cleared Philip's digital pathology system for marketing in the US.
The FDA cleared the Philips IntelliSite Pathology Solution, a whole-slide imaging system that enables the review and interpretation of digital surgical pathology slides prepared from biopsied tissue, through its do novo review pathway, making it the first time that the agency has allowed the marketing of a WSI system for such purposes, the agency said.
The automated Philips IntelliSite Pathology Solution comprises an ultrafast pathology slide scanner, an image management system, and a display. Advanced software tools allow users to manage the scanning, storage, presentation, review, and sharing of information.
For the review process, the FDA evaluated data from a clinical study of about 2,000 surgical pathology cases using tissue from different parts of the body. Sixteen pathologists from the Cleveland Clinic, University of Virginia, Miraca Life Sciences, and Advanced Pathology Associates conducted about 16,000 reads across 2,000 cases, Philips said. The study results found that diagnoses made based on the Philips images were comparable to those made using glass slides, FDA added.
The system digitizes slides that would otherwise be filed in physical files, providing a "streamlined slide storage and retrieval system that may ultimately help critical health information available to pathologists, other healthcare professionals, and patients faster," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in a statement.
In a separate statement, Russ Granzow, general manager of Philips Digital Pathology Solutions, said that the clearance will "promote increased efficiencies and collaboration between pathologists … [and] opens a complete new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care."