The FDA permission, which the agency announced April 12, marks the first time the agency has allowed the marketing of a WSI system for evaluation of biopsied tissue slides.
“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, 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,” Gutierrez said.
The FDA reviewed PIPS through the de novo premarket review pathway. A clinical study of roughly 2,000 surgical pathology cases found that diagnoses based on the PIPS images were comparable to those made using glass slides.
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