First digital pathology system gets FDA go-ahead

PARCA eNews – April 12, 2017 – Phillips IntelliSite Pathology Solution (PIPS) announced today it has been given FDA approval to market its first whole slide imaging system ushering in the era of digital pathology.

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.

“The system enables pathologists to read tissue slides digitally in order to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” said 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. 

In pathology, biopsied tissues are mounted onto glass slides and stained for viewing and evaluation. The PIPS uses proprietary hardware and software to scan and digitize conventional surgical pathology glass slides prepared from biopsied tissue at resolutions equivalent to 400 times magnification. These digitized images can then be reviewed and interpreted by pathologists.  

The digitized slides can easily be stored in computer files, providing 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.

In its authorization, the FDA established special controls that must be met to assure the digital imaging system’s precision, reliability, and clinical relevance.