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# AI Prostate Cancer Detector Cleared by FDA
- URL: https://www.fdaweb.com/ai-prostate-cancer-detector-cleared-by-fda/
- Published: 2025-02-10T12:00:00.000Z
- Updated: 2026-09-14T14:52:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158633

FDA has cleared an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an *in vitro* diagnostic that uses artificial intelligence to generate heatmaps to identify small and rare missed prostatic cancers. The device was designed to act as a “safety net that assists pathologists in ensuring patients receive an accurate diagnosis,” the company says.

The “software-only” device analyzes scanned histopathology whole slide images from prostate core needle biopsies prepared from a tissue sample that has been preserved in formalin, then embedded in paraffin wax, and subsequently stained with hematoxylin and eosin dye, a standard procedure in histology to visualize cell nuclei, according to the company. “If tissue suspicious for prostate cancer is identified, the system provides case- and slide-level alerts, and includes a heatmap directing the pathologist to areas likely to contain cancer,” it says.

Clearance was based on data from precision and clinical validation studies conducted at multiple U.S. and European laboratories that demonstrated the device has a 99.6% positive predictive value for cancer heatmap accuracy, and identified a 13% rate of missed cancers in a cohort of consecutive patients initially diagnosed as benign, Ibex Medical says. “These missed cancer cases (false negatives) were subsequently verified by expert pathologists, confirming the product’s clinical utility and benefits compared with the current standard of care.”