Tag: PMA

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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FDA Approves First Liquid Biopsy Test for Use in Non-Small Cell Lung Cancer

| June 1, 2016 | 0 Comments

Exciting news today from FDA with news of approval of first liquid biopsy test for use in non-small cell lung cancer.  The cobas EGFR test is already approved for use in formalin-fixed paraffin-embedded (FFPE) tissue. This new use is intended for detection of these specific mutations in circulating-free tumor DNA (cfDNA) from plasma for first […]

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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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DPA Recommends Whole Slide Imaging Manufacturers Submit De Novo Applications to the FDA for Primary Diagnosis

| January 14, 2016 | 0 Comments

Collaboration with FDA Results in Opportunity for Streamlined Approval Process The Digital Pathology Association (DPA) announced today that it suggests digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA). WSI is a technology which […]

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A simple and effective high-yield plan for digital pathology system validation    

| August 27, 2014 | 1 Comment

Here it is – a simple, easy to perform, highly reproducible plan for manufacturer pre-market approval or laboratory self-validation for the intended use of endoscopic mucosal gastrointestinal biopsies. These specimens are extremely common in nearly every hospital or community laboratory as well as the large commercial reference laboratories, specialty laboratories that focus their interests on […]

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