GE Healthcare’s Omnyx Integrated Digital Pathology system awarded Health Canada clearance for routine diagnostic use

| April 28, 2013

Watch out U.S. Regulators – GE is coming for you next.  Recently GE Healthcare announced their Omnyx Integrated Digital Pathology (IDP) system received the CE Mark in Europe and last week mentioned Health Canada Class II Medical Device License.  The GE Healthcare vision of using technology, as discussed by Agent Smith in this video makes the case for digital pathology that has been discussed here previously – the 4 R’s – right slide on the right patient to the right pathologist at the right time.  

Dr. Andrew Evans, a pathologist at University Health Network has been a pioneer in the field of digital imaging and telepathology since 2003.  We met shortly thereafter at an APIII meeting and have enjoyed watching the progress made in their institution and on a broader scale from initially robotic systems to whole slides and now further developed integrated solutions to leverage their expertise and resources for pathology services.

Well done, Andrew, UHN and Omnyx.  Perhaps those of on this side of the border can take some of the lessons learned here and provide assurances to practicing pathologists that this technology can also be used safely and effectively for patient care in the U.S. healthcare system. 

OmnyxMississauga, ON -April 22, 2013– GE Healthcare announced today that the Omnyx™ Integrated Digital Pathology (IDP) system, developed in a joint venture with University of Pittsburgh Medical Center (UPMC), has obtained a Health Canada Class II Medical Device License.

This designation enables pathology professionals to use Omnyx IDP as a new diagnostic tool in creating, managing, storing, annotating, measuring, and viewing digital whole slide images for routine pathology use. In addition, the Omnyx Integrated Digital Pathology system is also licensed for use with whole slide images from specific third-party scanners, providing additional flexibility for customers to leverage their existing investments.

Pathology plays a critical role in diagnosing and treating cancer. Getting the right case, to the right pathologist, at the right time is important to help expedite accurate diagnoses. In Canada, greater demands in cancer care are influencing the way pathology services are delivered. Many Canadian healthcare organizations are seeking new ways to provide consistent and equitable access to high-quality pathology services for coordinated patient care. Recognizing these care delivery trends, in January 2011, GE established its Global Pathology Innovation Centre of Excellence (PICOE) in Toronto, with clinical partners and government support, to translate digital pathology into real care scenarios.

The Omnyx technology helps unite the pathology department by enabling collaboration, communication, and efficiency across the organization. By digitizing slide images and corresponding workflow, Omnyx IDP provides pathologists with powerful digital tools to quickly assimilate, analyze, and share pathology cases and associated patient information. This helps enable efficiencies related to case review and communication with colleagues or specialists in the field, regardless of location.

“Cancer is one of the leading causes of death in the world*. At GE, we envision a day when cancer is no longer a deadly disease,” says Mike Clarke, General Manager of GE Healthcare Canada IT. “Today’s announcement reinforces our commitment to cancer and reflects our current integrated portfolio and GE Healthcare’s $1B R&D investment to advance oncology solutions by 2016. The Omnyx technology will help improve efficiency for pathologists while enabling them to better connect and collaborate to provide enhanced patient care across Canada’s health care system.”

The University Health Network (UHN) Laboratory Medicine Program (LMP), one of the largest diagnostic labs in Canada and a recognized leader in the emerging field of digital pathology, was one of the beta and clinical test sites for the Omnyx IDP system. Dr. Andrew Evans, Director of Telepathology at UHN’s Laboratory Medicine Program says, “The collaboration between the Department of Pathology at the University Health Network and GE Healthcare/PICOE is a prime example of academia and industry partnering to validate and move new technology into routine care to benefit patients everywhere. Health Canada approval of the Omnyx digital pathology system for primary diagnosis helps to reassure pathologists that this technology can be used safely and effectively for routine diagnostic work.”

“We truly believe digital pathology will transform the practice of pathology over the next ten years,” explained Jim LaFrance, CEO of Omnyx. “That transformation begins with creating a comfortable user environment to enable the technology transition. We put a great deal of emphasis in designing the Omnyx system to provide an exceptional experience that helps pathologists make efficient use of their time and render confident diagnoses.”

*Source: http://www.who.int/mediacentre/factsheets/fs297/en/

 Press release source: GE Healthcare


Category: Pathology News

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