FDA Radiology AI Devices

Cleerly LABS (v2.0) is a web-based software tool designed to help trained medical professionals analyze cardiac computed tomography (CT) images from Coronary CT Angiography (CCTA) scans. It uses machine learning to segment and label coronary arteries, assess plaques, stenosis, and vessel measurements, improving the efficiency and accuracy of coronary artery disease (CAD) assessment. The software enhances medical imaging workflows by automating complex, time-consuming tasks while providing interactive 2D and 3D visualizations.

LVivo Seamless is a software platform designed to automatically process echocardiogram ultrasound images to detect, measure, and calculate important cardiac medical parameters. It helps clinicians by selecting the appropriate image clips and activating AI modules to evaluate ejection fraction (EF) and global longitudinal strain (GLS), improving workflow and providing quantitative cardiac function data for better diagnosis and monitoring.

The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.

Myomics is a software tool designed to assist clinicians in viewing, processing, and quantitatively analyzing cardiovascular magnetic resonance (MR) images. Using AI-powered algorithms, it helps in detailed assessment of heart structures and adjacent vessels to support diagnosis in adult patients based on images acquired from 3.0 T MR scanners.

The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.

AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.

Ultrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.

Strain AI is a medical software device that analyzes cardiac ultrasound images to measure global longitudinal strain (GLS), helping clinicians assess heart function in adult patients. It integrates with existing ultrasound devices to provide quantitative strain measurements, supporting diagnostic evaluation without requiring manual interpretation of images.

TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.