Miraca Research News: Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary diagnostic use in the US

Pathologists at Inform Diagnostics contributed significantly in the development of a new product from Philips, the IntelliSite Pathology Solution. As one of four clinical study sites, Inform Diagnostics participated in “one of the largest studies ever conducted to directly compare the use of digital pathology to optical microscopes.” At Inform Diagnostics, participation in the Philips study was a project of Inform Diagnostics Research & Development Services.

As stated in its recent announcement, Philips “has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) to market its IntelliSite Pathology Solution, a comprehensive digital pathology system.”

The announcement specifies: “Sixteen pathologists at four clinical study sites – Cleveland Clinic, University of Virginia, Inform Diagnostics and Advanced Pathology Associates – conducted approximately 16,000 reads across 2,000 cases.”

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