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

April 13, 2017

  • First digital pathology solution to be cleared for primary diagnostic use in the U.S.
  • Regulatory clearance1 signals significant leap forward for pathology services industry and is expected to boost adoption of digital pathology
  • FDA issues news release 'FDA allows marketing of first whole slide imaging system for digital pathology'

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it 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 designed to meet the challenges of today's pathology lab.

As the first and currently only digital pathology solution in the U.S. to receive clearance for primary diagnostic use, the technology can aid pathologists to view and diagnose digital images of surgical pathology slides. Digital pathology aims to reduce pressure on pathology services by streamlining workflow and extending collaboration with the aim of increasing diagnostic confidence.

"The clearance for Philips IntelliSite Pathology Solution marks a major milestone for innovation in pathology services in the U.S.," said Russ Granzow, General Manager of Philips Digital Pathology Solutions. "Not 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."

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