First Digital Pathology Slide System Receives Marketing Approval

The U.S. Food and Drug Administration (FDA) has allowed marketing for the Philips IntelliSite Pathology Solution (PIPS), a digital imaging system for reviewing and interpreting pathology slides.

PIPS is an automated system for making, viewing, and managing whole slides of formalin-fixed, paraffin-embedded tissue. This is the first time the FDA has permitted the marketing of a whole-slide imaging system for these purposes. The PIPS system was reviewed through the FDA’s de novo premarket review pathway, a risk- and evidence-based classification process for low- to moderate-risk devices that have no substantial equivalent on the market.

The agency evaluated data from a multisite, multireader, multi-organ, multimodality clinical study of 2,000 surgical pathology cases. The review found that diagnoses made based on PIPS images were comparable to those made via glass slides, with a 0.4 percent discordance rate that was not statistically significant. An evaluation of intersystem precision data and intersite reproducibility provided an overall intersystem agreement rate of 90.2 percent.

Source: FDA news release, April 12, 2017.