Ibex Prostate Detect - Ibex Prostate Detect is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Ibex Prostate Detect detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer.Ibex Prostate Detect is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Ibex Prostate Detect user interface.Ibex Prostate Detect outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
2025-07-17