The days of pathologists examining tissue samples on glass slides under a microscope may be drawing to an end. New technology granted marketing rights on April 12 by the Food and Drug Administration enables the review and interpretation of digital surgical pathology slides prepared from biopsied tissue.
Philips Medical Systems received the FDA approval for its Philips IntelliSite Pathology Solution, or PIPS.
“The system enables pathologists to read tissue samples digitally in order to make a diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” Albert Gutierrez, director of FDA’s Office of In Vitro Diagnostics and Radiological Health said.
The approach has the potential to bring efficiencies to healthcare organizations by digitizing pathology processes that have relied extensively on physical storage of specimens.
“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 healthcare professionals and patients faster,” Gutierrez says.
Pathologists are scientists practicing the study of disease and making diagnoses by examining tissues, organs, body fluids and autopsies. In contrast to the current practice of mounting tissue on a slide and applying stain to ease viewing and evaluation, PIPS scans and digitizes conventional slides with resolution of as much as 400 times magnification.
Using PIPS, pathologists still must put a tissue sample on a slide, but then a digital picture is taken, enabling the corresponding increase in resolution.
When slides are digitized, they are available for query in a database, as opposed to current practices of slides placed in a physical filing system that the pathologist thumbs through to find the right slide.
Readings, the FDA cautions, don’t change because the samples are on a digital platform.
In clearing PIPS to enter the market, FDA used a recently adopted accelerated review and decision process that quickens approval of new low or moderate risk innovations not substantially equivalent to already-marketed devices in an effort to speed medical innovation.
FDA approval came after the agency evaluated data from about 2,000 pathology cases using tissues from many parts of the body. Results found that diagnoses made using PIPS images were comparable to findings using glass slides. Risks of using PIPS are similar to those of conventional microscope findings.
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