FDA Radiology AI Devices

Visage Breast Density is a software application designed to analyze mammography images and classify breast density into categories according to the ACR BI-RADS Atlas 5th Edition. It uses a convolutional neural network to assist radiologists by providing adjunctive information about breast tissue composition, making breast density assessment more efficient.

WRDensity by Whiterabbit.ai is a software tool that uses deep learning to analyze digital mammography images and automatically assess breast tissue composition according to the ACR BI-RADS 5th Edition breast density categories. It helps radiologists by providing breast density categorization and probability scores, which can improve breast cancer risk assessment and patient management. The software works with various mammography systems and outputs results to PACS and RIS for clinician review.

The Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.

MEDO ARIA is a cloud-based medical imaging software that uses machine learning to help clinicians view, quantify, and generate reports from ultrasound images of infant hips. It supports diagnosis of developmental hip dysplasia (DDH) in newborns and infants up to 12 months, assisting radiologists by automating some image analysis tasks and improving workflow efficiency.