Ibex Medical Analytics (Ibex) announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic medical device that harnesses AI to generate heatmaps identifying small and rare missed prostatic cancers.
Ibex Prostate Detect is a software only device that analyzes scanned histopathology whole slide images (WSIs) from prostate core needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded tissue. The device is intended to identify tumors that may have been missed by the pathologist. 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.
Deployed globally in routine clinical use, the Ibex platform includes prostate, breast and gastric solutions that provide pathologists with robust AI-powered tools to support detection of cancer and other clinically relevant findings and improve case review workflows. The platform includes solutions that are CE-IVD certified (per IVDR framework) and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. Ibex Prostate Detect is FDA cleared and other solutions are Research Use Only (RUO) in the United States. Ibex's quality and security certifications include HITRUST, Cyber Essentials Plus, ISO 27001 and ISO 13485, among others. For more information about the Ibex platform, please visit: https://ibex-ai.com.
Ibex Prostate Detect is formerly known in the US as Galen Second Read.
