FDA: Marketing for first whole slide imaging system for digital pathology approved

The U.S. Food and Drug Administration (FDA) approved the marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue.

“The system enables pathologists to read tissue slides digitally in order to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” said Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, in a statement. “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.”

Data for the PIPS was reviewed by the FDA through a regulatory pathway for devices of a new type with low to moderate risk that are not substantially equivalent to an already legally marketed device.

The FDA assessed data from a clinical study that included about 2,000 surgical pathology cases using tissue from various parts of the body. Researchers of the study found that diagnoses made based on the PIPS images were comparable to those made using glass slides.

This being the first time the FDA has authorized the marketing of an WSI system for these purposes, special controls are being established to ensure the digital imaging system’s precision, reliability and clinical relevance. The risks that this technology carries are similar to those associated with conventional light microscopy.