The FDA has cleared the way for pathologists to use whole-slide imaging when they view and interpret digital surgical pathology slides prepared from biopsied tissue. The Philips IntelliSite Pathology Solution is the first such system to receive the agency’s approval for primary diagnostic use.
“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 FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.