Paige Prostate receives FDA approval for AI Product in Digital Pathology

Paige, the global leader in AI-based diagnostic software in pathology, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Paige Prostate, a clinical-grade AI solution for prostate cancer detection. As a novel technology, Paige Prostate is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic (IVD) use via Paige’s FDA-cleared FullFocus™ digital pathology viewer.

With a projected 60 percent increase in the number of cancer cases globally in the next two decades and a decrease in the number of pathologists relative to this diagnostic demand, there is a significant need to provide new technologies for the practice of pathology. Paige Prostate is a cancer detection solution that identifies foci suspicious for cancer and provides this information to the pathologist. Paige Prostate is designed to assist pathologists in finding small foci of cancer and enable pathologists to work efficiently and confidently in their diagnostic process.