Omnyx Achieves CE Mark in the EU For Primary Diagnosis

| June 22, 2014
Building on news from last year (see: Omnyx Acquires CE Mark in Europe), Omnyx recently announced more significant news with their approval for their Integrated Digital Pathology (IDP) solution with the new VL120 high volume scanner for primary diagnosis. Great news for getting the right slide on the right patient to the right pathologist at the right time, breaking down geographic and time barriers for departmental and collaborative communication across an enterprise.  For more information on the mark, implications, legalities, manufacturer responsibilities and participating countries, click here.
Omnyx VL4 scanner
GE Healthcare has announced that the Omnyx™ Integrated Digital Pathology (IDP) solution with the new VL120 high volume scanner has acquired the CE Mark for primary diagnosis in the European Union under the ‘In Vitro Diagnostic Devices Directive’.
 The Omnyx™ IDP solution has been developed by Omnyx LLC, a joint venture of GE Healthcare and University of Pittsburgh Medical Center (UPMC).
In 2013, Omnyx™ IDP solution was approved for routine diagnostic use with the Omnyx™ VL4, a slide scanner designed for lower volume uses. This solution is installed at customers in Switzerland, Spain and the UK.  Now the new high volume scanner will give histopathologists even greater speed and efficiency to scan slides, create case files and manage their workflow.
Mamar Gelaye, CEO of Omnyx, said: “Most care pathways for patients rely on access to efficient and expert pathology services – from initial diagnosis, assessing progress and ongoing monitoring. Yet to date we have seen little investment in technology to empower histopathologists – who examine tissue slides. Traditionally, pathologists examine tissue slides under a microscope. Slides have to be transported to pathologists, or pathologists have to travel to other laboratories, creating delays in diagnosis and risk of slides being damaged or lost. This makes collaboration with and access to sub-specialists more difficult.
Now, we have our integrated digital pathology solution in Europe which gives pathologists powerful digital tools and the opportunity to transform how they work – speeding up the preparation of slides and case files  and reducing the time patients spend anxiously waiting for results. It helps connect pathologists and sub-specialists wherever they are in the world to improve accuracy of diagnosis.  With the addition of this high volume scanner, there is an opportunity to create even greater efficiency in the diagnostic process.
Designed in collaboration with histologists and pathologists, the Omnyx™ VL120 scanner’s intuitive workflow enables histology labs to manage high case volumes with continuous loading capability, adapting to the labs’ slide production schedule.  With this addition to the platform, the Omnyx™ IDP solution can enable more patients to have access to collaborative and subspecialty pathology services.

 


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Category: Anatomic Pathology, Clinical Laboratories, Device Manufacturers, Digital Pathology News, International, Laboratory Management & Operations, Marketing, Pathology News, TeleHealth, Vendor products, Web/Tech, Whole slide

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