FDA clears Ibex Prostate Detect
June 2025—Ibex Medical Analytics has received FDA 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic, software only medical device that analyzes scanned histopathology whole slide images from prostate core needle biopsies prepared from H&E-stained formalin-fixed, paraffin-embedded tissue. If tissue suspicious for prostate cancer is identified, the system provides case- and slide-level alerts and includes an AI-generated heat map that identifies small and rare missed prostatic cancers.