The FDA has granted Philips the first regulatory clearance for a whole slide imaging digital pathology system to be used as a primary diagnostic tool. The Philips IntelliSite Pathology Solution (PIPS) is a package of software and devices that lets pathologists image, analyze, and collaborate on biopsy samples coming to their lab. The technology frees doctors from conventional microscopes and allows for managing of digital files rather than physical slide samples.
A clinical study at four clinical facilities involving 16 pathologists and 2,000 patient cases found that the system performs comparably to traditional microscopy. Unlike the conventional way, digital pathology can significantly speed up the workings of a clinical laboratory and make it more efficient. A lot of the process is automated and high resolution images pop up on large-screen displays for easy review. Everything is right-side-up, scrolling across the slide is easy, and everything is well in focus.
From the FDA’s statement:
The FDA reviewed the data for the PIPS through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low- to moderate-risk that are not substantially equivalent to an already legally marketed device. The FDA evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple parts of the body (anatomic sites). Results of the study found that clinical interpretations (diagnoses) made based on the PIPS images were comparable to those made using glass slides.
Product page: Philips IntelliSite Pathology Solution…
Via: Philips…
