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...

I recently had an opportunity to speak with Esther Abels, Director of Regulatory, Clinical and Medical Affairs for Philips Digital Pathology Solutions about Philips’ recent approval to market their Philips Intellisite Pathology System (PIPS)...

The Digital Pathology Association (DPA) recently announced its suggestion that digital pathology manufacturers currently interested in marketing Whole Slide Imaging (WSI) devices for primary diagnosis in the United States submit de novo...

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...