FDA Approves the Philips Digital Pathology WSI Solution for Primary Diagnosis

As many of the readers of this blog already know, the Philips platform for digital pathology was recently approved by the FDA for the primary diagnosis of cases using WSI (see:FDA allows marketing of first whole slide imaging system for digital pathology). Primary diagnosis with digital pathology has been a long slog but we have now turned a major corner. Philips presented a webinar yesterday about PIPS (Philips IntelliSite Pathology Solution) which is accessible on-line (see:Philips IntelliSite Pathology Solution now available for primary diagnostic use in the U.S.) Here's thelink to the video. The recording is password protected so use the following password: primary_diagnostic_use.A sizable portion of the presentation is by Dr. Mike Feldman, a pathologist at the University of Pennsylvania, who lead the team that gathered the evidence presented to the FDA to justify the approval by the agency. HIs presentation is smooth and crystal clear. A convincing case has now been made that digital scans and analysis equals that of the predicate device, the microscope. The FDA has also decided that PIPS is a Class II device which is not as high a regulatory barrier as the previously determination as a Class III device. This latter requirespre-market approval (PMA) for changes.In my mind, the path is now clear for all...

Source: Lab Soft News - May 5, 2017 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Digital Imaging in Pathology Food and Drug Administration Healthcare Information Technology Lab Industry Trends Lab Processes and Procedures Lab Regulation LIS Definitions and Strategy Medical Research Pathology Informatics Source Type: blogs