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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

The system uses proprietary hardware and software to scan and digitise conventional surgical pathology glass slides prepared from biopsied tissue
14 Apr 2017
Pathology/Molecular biology

On 12 April, 2017 the US Food and Drug Administration (FDA) permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.

“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, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Because the system digitizes slides that would otherwise be stored in physical files, it also 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.”

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 PIPS is an automated digital slide creation, viewing, and management system that will allow pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.

The FDA reviewed the data for the PIPS through the de novo premarket review pathway to provide a reasonable assurance of safety and effectiveness of the device. During this process, the FDA evaluated data from a multi-site, multi-reader, multi-organ, multi-modality clinical study of approximately 2,000 surgical pathology cases. Efficacy was determined as whether the major discordance rate of the digital WSI modality was non-inferior to the discordance rate of the glass slide modality. The study determined MD (Manual Digital) major discordance rate of 4.7%, MO (Manual Optical) major discordance rate of 4.4%, and MD-MO rate difference of 0.4% (difference does not equal 0.3 due to rounding) with a 95% confidence interval of (-0.30%; 1.01%). The clinical reference standard was based on the original pathology report.

The FDA also evaluated data from a feature study to evaluate both inter-system precision and inter-site reproducibility for the PIPS. The overall inter-system agreement rate was 93.8% with a 95% CI of (92.6%; 95.0%). The overall inter-site agreement rate was 90.2% with a 95% CI of (87.9%; 92.4%).

In this authorisation, the FDA is establishing special controls that must be met to assure the digital imaging system’s precision, reliability, and clinical relevance. The risks associated with use of this technology are similar to that of the use of conventional light microscopy. These special controls are necessary to provide reasonable assurance of safety and effectiveness for this digital imaging system.

Further information about the PIPS is available here.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System. 

The FDA permitted marketing of the Philips IntelliSite Pathology Solution to Philips Medical Systems Nederland B.V.

Last update: 14 Apr 2017

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