Israel-based cancer diagnostics provider Ibex Medical Analytics (Ibex) has received the US Food and Drug Administration (FDA) 510(k) approval for Ibex Prostate Detect.
Ibex Prostate Detect is a software-only device designed to analyse scanned histopathology whole slide images (WSIs) from prostate core needle biopsies.
The samples are prepared from haematoxylin and eosin (H&E) stained formalin-fixed paraffin-embedded tissue.
The in-vitro diagnostic medical device leverages AI to generate heatmaps to identify small and rare tumours that may have been missed by the pathologist.
When a tissue suspicious of prostate cancer is identified, the test provides case- and slide-level alerts, including a heatmap directing areas likely to contain cancer.
The test serves as a safety layer that supports pathologists in providing accurate diagnoses, said Ibex.
Ibex Medical Analytics CEO Joseph Mossel said: “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.
“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.”
Ibex conducted large-scale clinical validation studies at multiple sites in the US and Europe.
In the studies, Prostate Detect showed a 99.6% positive predictive value (PPV) for cancer heatmap accuracy and identified 13% missed cancers that were initially identified as benign.
The missed cancer cases were later verified by expert pathologists, confirming the product’s clinical utility and benefits compared with the current standard of care.
Ibex scientific advisor Mahul Amin said: “Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime.
“With the global incidence expected to double by 2040, accurate and timely diagnoses are more critical than ever.
“Advancements in AI-powered pathology can support pathologists in delivering precise and efficient diagnoses, ultimately improving patient outcomes.”
According to the company, cancer incidence is increasing worldwide, with the demand and diagnostic workloads compounded by a global shortage of pathologists.
Ibex said its platform will help address these challenges by providing pathologists with AI tools that enhance accuracy and streamline workflows.
The platform includes prostate, breast and gastric solutions that provide pathologists with advanced AI-powered tools to support the detection of cancer and other findings.
It enables accurate and timely diagnosis and plays a key role in both guiding treatment decisions and improving survival rates of patients with cancer, said the company.
