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FDA Approves AI Tool for Better Prostate Cancer Detection

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The U.S. Food and Drug Administration (FDA) has approved Ibex Prostate Detect, an AI-powered software that helps doctors find prostate cancer in tissue samples. This tool, formerly known as Galen Second Read, uses artificial intelligence (AI) to scan biopsy slides and highlight areas that may have cancer.

Ibex Prostate Detect creates heatmaps, which are color-coded images that help pathologists spot small or hard-to-find tumors. If the AI finds something suspicious, it sends an alert to doctors, helping them make more accurate diagnoses.

Prostate cancer is one of the most common cancers, affecting 1 in 8 men in their lifetime. With cases expected to double by 2040, early and accurate diagnosis is crucial. AI-powered tools like Ibex Prostate Detect can support doctors in making faster and more precise diagnoses, improving patient care.

Studies show that the software has a 99.6% accuracy in its heatmaps and was able to detect 13% of cancer cases that were missed by doctors during the initial review. In a clinical study, the tool achieved high accuracy in identifying different cancer types and stages.

This FDA approval is the first for Ibex Medical Analytics and strengthens confidence in AI-assisted pathology. The company also offers AI solutions for diagnosing breast and gastric cancers. Ibex CEO Joseph Mossel stated that this milestone highlights their commitment to improving healthcare with AI technology.

Source: urologytimes