Royal Philips, leaders in healthcare technology, have received De Novo clearance from the U.S. Food and Drug Administration (FDA) to market their IntelliSite Pathology Solution. The digital pathology system aids pathologists in improving workflow and is currently the only digital pathology system to receive clearance for primary diagnostic use.
Philips IntelliSite Pathology Solution is an automated digital pathology image creation, viewing and management system made up of pathology slide scanners, an image management system and display. With additional software tools to aid in the management of scanning, storage, presentation, reviewing, and sharing of information, the system simplifies access to information and improves efficiency.
"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."
In testing the efficiency of the system, the FDA studied data from a clinical trial of 2,000 surgical pathology cases. These cases were reviewed by a team of 16 pathologists from Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates. As the number of cancer cases continue to grow, Philips hopes the system will improve workflow and efficiency of complex pathological cases and move toward high quality personalized treatment.