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FDA Approves Marketing of Whole Slide Imaging System, First of Its Kind

FDAApril 13, 2017—Yesterday, the U.S. Food and Drug Administration approved the marketing of Philips IntelliSite Pathology Solution (PIPS). PIPS is the first whole slide imaging system that has been approved by the FDA. This new technology is set to replace traditional methods of tissue biopsy viewing, which required glass slides to be viewed under a light microscope.

PIPS utilizes proprietary technology to scan and digitize glass slides at up to 400x magnification. Pathologists are then able to review and analyze these digitized slides, saving time and resources, all while streamlining the storage process.

In a statement on the approval, the Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, Alberto Gutierrez, Ph.D., said, “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.”

In an evaluation of approximately 2,000 cases it was found that pathologists relying on PIPS images were able to make comparable diagnostic decisions to those using traditional glass slides. The FDA concluded that the risks associated with this technology are similar to those in conventional light microscopy.

Marketing of PIPS has been granted to Philips Medical Systems Nederland B.V.



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