FDA Allows Marketing of First Whole Slide Imaging System

The system will allow for digital pathology

The FDA has announced it has permitted the marketing of the Phillips IntelliSite Pathology Solution (PIPS), which is the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. The is the first time the FDA has allowed the marketing of a system like this.

“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, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.”

The FDA reviewed the PIPS data, and determined the diagnoses were comparable to those made using glass slides.

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