Tag: 510(k)

WSI Device Clearances After the Philips De Novo Classification: An Outlook on the Regulatory Road Ahead

| September 22, 2017 | 0 Comments

By Christopher Ivicevich, Director of Regulatory Affairs & Quality Compliance, OptraSCAN With the recent shift in the industry as the result of this decision, a common question is “What lies in store for digital pathology system manufacturers in the wake of the FDA granting Philips’ de novo classification request for its IntelliSite device?” First, What […]

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Omnyx Applauds FDA and Digital Pathology Association on Recent Collaboration 

| January 17, 2016 | 0 Comments

Last week news was released after months of speculation, that the FDA would consider the de novo classification option for digital pathology systems as a pathway for bringing to market a moderate or low risk device which has not yet been classified, and for which there is no predicate device (as in whole slide imaging systems). If the FDA […]

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Full digitization of the anatomic pathology lab is here with the VENTANA System for Primary Diagnosis

| August 21, 2014 | 0 Comments

More positive news coming from Ventana with its CE Mark in the EU for routine pathology, including primary diagnosis.   New CE mark in the European Union extends application to routine pathology including primary diagnosis with human tissue specimens TUCSON, Ariz., Aug. 20, 2014 /PRNewswire/ — Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced that its VENTANA […]

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