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 the link 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 requires pre-market approval (PMA) for changes.

In my mind, the path is now clear for all pathology departments -- an urgent need to deploy this technology which opens up a new set of opportunities and challenges. The major challenges for departments will be modifying their surgical pathology workflow and integrating digital pathology with their LISs. From an automation perspective, surgical pathology will soon be comparable to clinical pathology, at least from the image scanning and analysis perspective. My advice to graduating medical students seeking to pursue a career in pathology is to choose a department for training that will be able to smoothly deploy digital pathology efficiently and broadly.

Comments

[Ole Eichhorn]

This is big news indeed, congratulations to Philips! I’ve always thought that FDA approval, while most important, would not be a tipping point. The economics have to be there first. But now we will see!

[Steve A McClain, MD]

The second concern is HOW, or method of showing pathology images which has inordinant influence on how much time is wasted/needed while we
Confirm the case#
Confirm the site
find and organize the diagnosis,
measure size and depth,
Save measurement data to the report,
get images to the report,
mark up image features for conference, etc.

Kindly show me software with few mouse clicks to save me time.

[Steve A McClain, MD]

NO WAY. I have great respect for Dr. Feldman's work and applaud this new tool. I hope it will save me time. Or free me from the scope and permit more travel. But the 800 pound gorilla is that microscope images on screen STINK by comparison to the vivid microscope view. Not even close. Digital cameras see differently. In one sense they are colorblind.

We can adapt. Digital slide scanning is here and may be the future of pathology in large labs, but the best pathologists won't give up their direct microscopic exam. Examination of digital images can be comparable in simple cases with positive results, like prostate cancer or basal cell carcinoma, this technology can augment our vision and extend our practice, but it is still derivative data.

My greater concern is image quality. Onscreen images stink when compared to my visual in the scope oculars. Cameras only perceive 1% of what my eyes see directly through the microscope, and this is true at each and every power. Sharpness, contrast, and especially true color suffer in the translation to computer screen.

In my pathology experience, there is more to analysis than a picture. Seeing happens when the humans interact w the scope, the act of physically moving the slide causes the brain to assemble a 3D construct. Countless times have I seen the essential diagnostic clue or cluster of cells, or fungal hyphae just AFTER GIVING UP. As I pulled the slide off the microscope stage, my eye latched on to that particular previously unseen cluster, visible because of rapid or erratic movement.
Adjusting Focus up and down is a mental exercise in z-stacking we pathologists use every day. Add a polarizer, close down the condenser, or boost the voltage to deliberately shift color are among other tricks of the pathologist trade.

The pathologist embedded in the process of micro-image formation, tweaking and optimizing 'sees' the critical features.

Whole slide scanning is on the horizon, but the main impetus may come from the next crop of medical students who have never seen a microscope slide or owned a microscope in school.