FDA Radiology AI Devices

MammoScreen BD is an AI-powered software designed to assist radiologists by automatically analyzing mammography images. It helps detect and assess breast density, improving the accuracy and consistency of breast cancer screening and diagnosis.

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.

TumorSight Viz is an automated radiological image processing software designed to assist clinicians by analyzing medical images for tumor-related information, potentially improving diagnosis and treatment planning for patients with tumors.

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging Inc. is a computer-assisted diagnostic tool designed to assist clinicians in evaluating lesions suspicious for cancer, potentially improving diagnostic accuracy in radiology.

Velacur One (LI-1100) is a portable ultrasound elastography device designed to non-invasively assess liver tissue stiffness, ultrasound attenuation, and fat content by measuring shear wave speed and ultrasound properties. It assists trained clinicians in managing liver diseases including hepatic steatosis by providing quantitative imaging data at the point of care in clinics and hospitals.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are sophisticated diagnostic ultrasound devices that integrate deep learning AI technology to assist clinicians in cardiac imaging. Their Smart View Select software automatically classifies and selects optimal ultrasound images for left ventricle analysis in echocardiography, enhancing workflow and diagnostic accuracy for cardiac assessment. These systems are used by trained healthcare professionals in clinics and hospitals for a broad range of diagnostic ultrasound applications.

BrightHeart View Classifier is a cloud-based AI-powered software designed to analyze 2D fetal ultrasound images and video clips to automatically identify and classify standard fetal heart views. It assists trained healthcare professionals in acquiring and interpreting fetal heart ultrasound exams in the second and third trimesters by providing annotated outputs and validating whether scanning protocols are met, improving diagnostic workflow and consistency.

BrightHeart View Classifier is an AI-powered software that automatically analyzes fetal ultrasound images and video clips to identify standard views of the fetal heart during scans. It helps healthcare professionals by improving the acquisition and interpretation of fetal heart ultrasound exams, making fetal heart imaging more efficient and consistent.