FDA clears Ibex Prostate Detect

Feb. 11, 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. In precision and clinical validation studies conducted at U.S. and European laboratories as part of the FDA clearance, the system demonstrated a 99.6 percent positive predictive value for cancer heat map accuracy and identified a 13 percent rate of missed cancers in a cohort of consecutive patients initially diagnosed as benign, the company said in a press statement.