FDA approves first digital pathology system for primary diagnosis

The U.S. Food and Drug Administration (FDA) recently announced the approval of the first whole slide imaging (WSI) system that allows for primary diagnosis based on review and interpretation of digital surgical pathology slides. This is a significant advancement by the FDA as WSI systems historically could not be used for primary diagnosis.

In surgical pathology, biopsied tissue is dissected, fixated, embedded and cut into very thin slices, which are then stained and permanently mounted on glass slides. The slides are then examined by a pathologist under a light microscope to arrive at a diagnosis. WSI, on the other hand, refers to the digitization of the stained tissue mounted on glass slides. When utilizing WSI, the tissue is prepared as it normally is for light microscopy. However, the slide is then converted into a digital whole slide image that the pathologist views on a computer monitor instead of through microscope oculars.

The approved WSI system, known as Philips IntelliSite Pathology System (PIPS), is manufactured by Philips. It was approved via de novo classification, which is the regulatory pathway for obtaining marketing clearance for new, low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. PIPS uses hardware and software to digitize conventional surgical pathology glass slides at resolutions equivalent to 400 times magnification. The images are then read and interpreted by pathologists.

In connection with its authorization of the PIPS system for primary diagnosis, the FDA evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple anatomic sites. The results of the study found that clinical diagnoses made based on PIPS images were comparable to those made using traditional glass slides. However, it is worth noting that the FDA is establishing necessary controls that must be satisfied to assure the precision, reliability and clinical relevance of PIPS.

Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, stated that the system “provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other health care professionals and patients faster.”

Russ Granzow, General Manager of Philips Digital Pathology solution, shared similar sentiments and stated “[n]ot only will it promote increased efficiencies and collaboration between pathologists, but it also opens a complete new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care.”

Digital slides are considered to contain more information and data than what the human eye is able to see utilizing a microscope. Ultimately, the use of WSI for primary diagnosis is expected to reduce laboratory expenses and improve operational efficiency as well as enhance productivity and improve treatment decisions and patient care. It may take time for the cost of the technology and payor reimbursement policies to reach a point that makes widespread adoption attractive.

For more information, contact one of the attorneys listed below.

Related Services

Jump to Page

McDonald Hopkins uses cookies on our website to enhance user experience and analyze website traffic. Third parties may also use cookies in connection with our website for social media, advertising and analytics and other purposes. By continuing to browse our website, you agree to our use of cookies as detailed in our updated Privacy Policy and our Terms of Use.