FDA Radiology AI Devices

The LVivo Software Application is an AI-based software platform that automates the analysis of ultrasound images, primarily to evaluate heart-left ventricle function and bladder volume. It helps clinicians by automatically detecting and calculating important medical parameters, improving diagnostic accuracy and efficiency in cardiology and related fields.

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.

HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.

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.

CaRi-Plaque is a web-based software application that aids trained medical professionals by automatically analyzing cardiac CT scans to quantify and characterize coronary artery plaques and stenoses. It provides detailed measurements on plaque volumes and vessel stenosis to help clinicians assess coronary artery disease and guide treatment decisions, complementing their clinical judgment.

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.

The Vivid T9/Vivid T8 is a diagnostic ultrasound system primarily intended for cardiac imaging but also supports vascular and general radiology applications. It provides digital acquisition, processing, measurement, display, and analysis of ultrasound images using various transducers and imaging modes. The system supports a range of clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, helping healthcare professionals in hospitals and clinics obtain real-time detailed images for diagnostic purposes.