Philips’ Whole Slide Imaging System Wins FDA Approval

April 17, 2017

The FDA has granted de novo clearance for a Philips’ imaging system that allows pathologists to read and interpret tissue slides digitally, rather than directly from a microscope.

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.

Because the system digitizes slides that would otherwise be stored in physical files, it 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,” said Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics.

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