Royal Philips (NYSE:PHG) said today that Massachusetts General Hospital will operate as the key testing site for a precision study of its Intellisite Solution digital pathology whole slide imaging.
The study aims to examine the reproducibility of the IntelliSite pathology solution in disease detection as “part of the industry’s efforts to obtain regulatory clearance of WSI for primary diagnostic use,” the company said.
“With rising health care costs, we have a public responsibility to work effectively. Through the genomic revolution we have started to learn how to manage big data. Now there is a pressing need to gain access to and increase flexibility in how pathologists manage the massive amounts of imaging data we procure every day,” principal investigator Dr. Jochen Lennerz said in a press release.
While most pathologists provide tissue based diagnoses through analysis performed on a microscope using glass slides, new technology aims to improve the process by moving the analysis onto a digital platform, Philips said.
“Through this study we hope to provide evidence for regulatory purposes that this technology is valid and reliable for primary diagnostic use,” study key enrollment pathologist Dr. Veronica Klepeis said in a prepared statement.
Philips said that “recent discussions” with the FDA have the potential to streamline the regulatory pathway for digital pathology WSI.
“Digital pathology addresses many of the inherent delays present in traditional pathology workflows and supports workplace efficiencies that can be scaled within organizations to streamline processes and cut costs. Philips is excited about the clinical study MGH is conducting to investigate the reproducibility of digital pathology system in the clinical diagnostic setting,” Philips digital pathology solutions GM Russell Granzow said in preapred remarks.
Earlier this week, Philips won a maximum $77 million modification through the U.S. Department of Defense as the 7th year in a possible 9-year contract for medical equipment.
The contract positions Philips to supply the DoD with patient monitoring systems, subsystems, accessories, consumables, spare or repair parts and training on the systems, and comes as a fixed-price with economic price adjustment contract.
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