NEW YORK ─ ContextVision said Monday that it has been granted CE marking for its Inify Prostate Screening digital pathology product, making it available for routine clinical use in the European Union.
Stockholm-based ContextVision said its Inify Prostate Screening artificial intelligence-based software predicts, outlines, and quantifies suspected cancerous areas in a series of prostate biopsies. It presorts slides in a worst-first order, allowing pathologists to work immediately on the most relevant areas.
The product can be used as a standalone unit or integrated into pathology laboratories’ existing Laboratory Information Systems (LIS) or Picture Archiving and Communication Systems (PACS).
Its predicting engine is built on deep learning algorithms, which have been trained and adapted by ContextVision’s research scientists to produce high-performance algorithms with pixel-level accuracy, the company said. The product employs multiplex immunofluorescent staining to objectively identify and highlight cancer areas and other structures that are quality assured by certified pathologists.
For two years, Cannizzaro Hospital in Catania, Italy, has been using a prototype of the product as part of its digital pathology workflow.