First Digital Pathology Solution Receives FDA Clearance

After evaluating data from a clinical study including around 2,000 surgical pathology cases, the US FDA has cleared the first digital pathology solution for primary diagnostic use in the U.S.

Digital pathology can help pathologists view and diagnose digital images of surgical pathology slides, streamline workflows in pathology departments, and increase collaboration and diagnostic confidence.


The US Food and Drug Administration (FDA) approval will now enable Royal Philips to market its IntelliSite Pathology Solution for the digital pathology lab.

As cancer cases increase, pathology services need to deal with an increasing number and complexity of tests for cancer care. Digital pathology has already helped increase efficiency in the primary diagnosis of histopathology images outside the U.S. since 2014.

The Philips IntelliSite Pathology solution automates the creation, viewing and management of digital pathology images and includes advanced software tools that help manage information sharing, and other services. Digital pathology can also use computational pathology tools that provide more accurate image analysis, and predictive health management.

General Manager of Philips Digital Pathology Solutions, Russ Granzow, said, “Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a complete new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care. The clearance for Philips IntelliSite Pathology Solution marks a major milestone for innovation in pathology services in the U.S.”