FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Paige Prostate is an AI software device by Paige.AI designed to assist pathologists in detecting prostate cancer in digitized pathology slides from needle biopsies. It analyzes whole slide images scanned from H&E stained tissue samples and identifies areas most suspicious for cancer, helping pathologists to focus their review and improve diagnostic accuracy. It serves as an adjunct tool and supports clinicians in making more accurate prostate cancer diagnoses.

Product Code
QPN
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