Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, 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, acting as a safety net that assists pathologists in ensuring patients receive an accurate diagnosis.

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.

“The FDA clearance marks a significant milestone in Ibex’s journey and exemplifies our dedication to developing clinically validated solutions that help improve patient health outcomes,” said Joseph Mossel, Chief Executive Officer at Ibex Medical Analytics. “This clearance affirms our commitment to the safety and efficacy of our AI solutions and strengthens our ability to provide cutting-edge innovation to pathologists, which ultimately benefit patients. We hope this accomplishment will bolster industry-wide confidence that AI-powered digital pathology is ready for widespread clinical adoption.”

In precision and clinical validation studies conducted at multiple US and European laboratories as part of the FDA clearance, the system demonstrated a 99.6% positive predictive value (PPV) for cancer heatmap accuracy and identified a 13% rate of missed cancers in a cohort of consecutive patients initially diagnosed as benign. 

These missed cancer cases were subsequently verified by expert pathologists, confirming the product’s clinical utility and benefits compared with the current standard of care.¹

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 the 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. 

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¹ Ibex precision and clinical validation studies submitted to the FDA (unpublished).