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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

Posted on by Drea

April 12, 2017

FDA News Release

The U.S. Food and Drug Administration today permitted 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. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.

“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.”

Pathologists are medical doctors who specialize in understanding the cause and development of a disease or condition. In pathology, biopsied tissues are mounted onto glass slides and stained for viewing and evaluation. The PIPS uses proprietary hardware and software to scan and digitize conventional surgical pathology glass slides prepared from biopsied tissue at resolutions equivalent to 400 times magnification. These digitized images can then be reviewed and interpreted by pathologists.

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