FDA Radiology AI Devices

Autoplaque 3.0 is a post-processing software designed for use with coronary CT angiography images. It helps cardiologists and radiologists analyze coronary arteries to detect and measure plaques and stenosis. The AI-driven software automates vessel, plaque, and lumen segmentation with an option for clinician review, enabling faster and more standardized cardiac image analysis.

AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.

MPXA-2000 is a software tool intended for cardiologists and radiologists to automatically analyze X-ray angiographic images of the coronary arteries. It uses deep learning and computer vision algorithms to segment blood vessels, classify vessel types, quantify vessel dimensions, and support clinical decisions related to coronary artery disease. The software provides validated, reproducible quantitative results to aid in diagnosis and treatment evaluation, with results available for review and export.

Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that processes cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, a critical measure of heart function. It helps clinicians quickly and accurately evaluate cardiac health by analyzing ultrasound video clips, selecting the best quality views, and calculating ejection fraction with confidence metrics. This supports clinical decision-making in adult cardiac evaluations.

The ZEUS System by iRhythm Technologies is a software platform designed to analyze ECG data from wearable cardiac monitors to detect arrhythmias and other heart rhythm abnormalities. It uses AI algorithms to automatically process and identify cardiac events, assisting clinicians in diagnosing and managing heart conditions by generating detailed reports from long-term ECG recordings.

Rapid RV/LV is a medical imaging software designed to assist clinicians by automatically measuring the sizes of the right and left heart ventricles from CT pulmonary angiography scans. It provides annotated images and quantitative measurements to help assess right-heart strain, supporting clinical decision-making in cardiopulmonary conditions. The software uses machine learning to locate the ventricles and report their size ratio.

LVivo IQS is a software application that processes ultrasound images of the heart to detect, measure, and calculate key medical parameters for patients with suspected cardiac disease. It provides real-time quality score feedback on image quality, helping clinicians ensure the accuracy and usefulness of cardiac ultrasound scans, particularly the left ventricle function from the 4 chamber apical view. This tool assists clinicians by improving the reliability of echocardiographic assessments.

The VX1+ by Volta Medical is an advanced cardiac mapping system that uses machine learning to assist clinicians by automatically or manually annotating 3D anatomical and electrical maps of the heart's atria. It helps identify areas exhibiting complex electrical activity during arrhythmias such as atrial fibrillation, potentially aiding catheter ablation procedures.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

The STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.