Canadian Licensure for the Use of Digital Pathology for Routine Diagnoses

 http://dx.doi.org/10.5858/arpa.2013-0289-ED

Bernard Têtu, Andrew Evans, (2013) Canadian Licensure for the Use of Digital Pathology for Routine Diagnoses. Archives of Pathology & Laboratory Medicine In-Press.

Early Online Release

Canadian Licensure for the Use of Digital Pathology for Routine Diagnoses

One More Step Toward a New Era of Pathology Practice Without Borders

Bernard Têtu, MD; Andrew Evans, MD

From the Department of Pathology, Université Laval, Centre Hospitalier Universitaire (CHU) de Québec, Québec, Canada (Dr Têtu); and the Department of Laboratory Medicine and Pathobiology, University Health Network, Toronto, Ontario, Canada (Dr Evans).

On April 22, 2013, GE Healthcare (Mississauga, Ontario, Canada) announced that the Omnyx Integrated Digital Pathology system, developed jointly with the University of Pittsburgh Medical Center (Omnyx LLC, Pittsburgh, Pennsylvania), had obtained a Health Canada Class II Medical Device License for creating, managing, storing, annotating, measuring, and viewing digital whole-slide images for routine pathology use. On May 9, a similar clearance was announced by Leica Biosystems (Vista, California). The University Health Network (UHN) Laboratory Medicine Program (Toronto, Ontario, Canada), one of the largest diagnostic labs in Canada, is one of several beta and clinical test sites for the Omnyx Integrated Digital Pathology system, generated the data that led to the Health Canada licensure, and has used Aperio ePathology (Vista, California) solutions since 2006.