FDA approves first digital pathology system for diagnostic use

Royal Phillips has received U.S. Food and Drug Administration (FDA) clearance for its IntelliSite Pathology Solution, a pathology image creation and management system. Its currently the only digital pathology system cleared for primary diagnostic use, an important milestone in the burgeoning field.

Just as picture archiving and communication systems (PACS) turned radiology on its head, systems like IntelliSite may be about to do the same for pathology. Digitized slides can reduce turnaround times, improve communication between physicians, and are well-suited to computer-aided detection, similar to the technology widely used in mammography.

Pathology occupies a similar role as radiology in hospital workflows, as a referral-based service. As many as 95 percent of clinical pathways pass through the pathology department, according to a 2013 NHS study, so increasing efficiency in pathology can improve the hospital as a whole.

While digital pathology systems have been used for primary diagnosis in Europe for several years, the FDA classified whole slide imaging (WSI) systems as Class III medical devices, requiring rigorous pre-market approval for each and every potential use. While some digital pathology systems have received FDA approval for narrow applications, Phillips swung for the fences with IntelliSite.

In order to win primary diagnostic approval, the Netherlands-based company conducted a four-site, 2,000-case clinical study pitting IntelliSite against actual pathology slides. After 16,000 total reads—one of the largest pathology studies ever—the FDA found interpretations based on digital slides were comparable to those using glass slides.

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