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Philips WSI system FDA OK’d for digital pathology

April 13, 2017—The FDA on April 12 permitted marketing of Royal Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging 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,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said 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.”

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.

The FDA reviewed the data for the PIPS through the de novo premarket review pathway and evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple anatomic sites. Results of the study found that diagnoses made based on the PIPS images were comparable to those made using glass slides.

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

In this authorization, the FDA is establishing special controls that must be met to assure the digital imaging system’s precision, reliability, and clinical relevance. The risks associated with use of this technology are similar to that of the use of conventional light microscopy. These special controls are necessary to provide reasonable assurance of safety and effectiveness for this digital imaging system.

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