Shots:
- The US FDA has granted 510(k) clearance to Ibex Prostate Detect, which generates heatmaps using AI to detect small & rare missed prostatic cancers
In studies, the device showed 99.6% PPV for cancer heatmap accuracy & detected 13% rate of missed cancer in pts initially diagnosed as benign, where these false negatives were later confirmed by pathologists - The device analyses scanned histopathology WSIs from H&E-stained, formalin-fixed, paraffin-embedded prostate core needle biopsies to identify missed tumors, plus provides case & slide-level alerts while also directing heatmap to cancer-containing areas. It also incl. solutions which are CE-IVD certified & are registered with the MHRA, TGA & ANVISA
Ref: Businesswire | Image: Ibex
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