FDA Radiology AI Devices

MetaLite DX Digital Pathology Software is a software-only medical device that helps pathologists view, interpret, and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It facilitates digital pathology diagnosis by providing tools for image viewing, zooming, measurements, and annotation, designed to enhance workflow with specific scanners and displays, thereby aiding in accurate and efficient pathology diagnosis.

The Genius Digital Diagnostics System with the Genius Cervical AI algorithm is an AI-powered digital imaging system designed to scan, analyze, and help interpret ThinPrep Pap test slides for cervical cancer screening. It identifies clinically relevant cellular objects and presents them in an easy-to-review format for cytologists and pathologists, improving diagnostic sensitivity while assisting in patient management.

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.