Tag: de novo

Q&A with Philips Digital Pathology

| June 23, 2017 | 0 Comments

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) for primary diagnosis of biopsies and excisions in the United States. My thanks to Esther and Philips’ marketing team for their […]

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Digital Pathology Association Acknowledges Collaborative Efforts with FDA for Whole Slide Imaging

| February 20, 2016 | 0 Comments

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 applications to the Food and Drug Administration (FDA) based on clarity and guidance provided to the DPA from the FDA. WSI technology is critical to advancement […]

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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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