FDA Radiology AI Devices

Transpara is an AI-powered software designed to assist radiologists in detecting and diagnosing breast cancer from screening mammograms. It highlights suspicious soft tissue lesions and calcifications and provides likelihood scores for cancer presence, helping clinicians make more informed decisions during mammogram interpretation.

ProFound AI Software V2.1 is an AI-based software designed to assist radiologists in detecting soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It highlights suspicious breast lesions by marking areas in the images and assigns confidence scores to help physicians identify likely malignant regions, supporting earlier and more accurate breast cancer diagnosis.

PowerLook Tomo Detection V2 Software by iCAD Inc. is an AI-based computer-assisted detection and diagnosis tool that helps physicians identify suspicious lesions and calcifications in digital breast tomosynthesis images. It provides confidence scores to assist in evaluating findings, improving radiologist accuracy and reducing reading time during breast cancer screening exams.

Transpara is an AI-powered software tool that helps doctors identify suspicious areas in mammograms that might be breast cancer. It highlights these areas, provides scores indicating the likelihood of cancer, and supports physicians in making more accurate diagnoses. This assists in earlier and more reliable detection of breast cancer during screening.