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...

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...

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...

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)...

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...