FDA Radiology AI Devices

CardIQ Suite by GE Medical Systems is a non-invasive software tool designed to analyze 2D and 3D cardiac CT images, helping clinicians visualize and measure cardiovascular anatomy, including vessels and chamber mobility. It uses advanced AI algorithms for automatic calcium scoring and labeling of calcified plaques, aiding in diagnosis and treatment planning of cardiovascular diseases like coronary artery disease. The software also facilitates tracking calcium progression and supports clinicians with integrated workflows for reviewing coronary CT angiography data effectively.

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

TOMTEC-ARENA is medical software designed to help clinicians review and quantify cardiovascular, fetal, and abdominal ultrasound images. It incorporates AI to provide semi-automated measurements, improving workflow efficiency while allowing users to edit or accept these measurements. This supports physicians in diagnosing suspected diseases by providing detailed and accurate imaging analysis.

EchoGo Core (2.0) is an AI-powered software that analyzes ultrasound images of the heart (echocardiograms) to automatically quantify and report cardiac function metrics. It assists physicians by providing measurements like ejection fraction, ventricular volume, and strain, helping in cardiovascular diagnosis for adult patients.

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.

The AHI System is a software tool that helps healthcare professionals monitor adult patients' cardiovascular status by analyzing ECG signals to detect signs of current hemodynamic instability and predict future episodes. It provides continuous updates and color-coded alerts for clinicians to increase vigilance and improve patient care.

IM007 by Implicity, Inc. is an AI-powered software that analyzes ECG data from Insertable Cardiac Monitors to help healthcare professionals detect various cardiac arrhythmias, such as atrial fibrillation and ventricular tachycardia. It works by processing ECG signals remotely uploaded from compatible devices and provides analysis results to clinicians to support diagnosis and patient monitoring.

The Irregular Rhythm Notification Feature 2.0 (IRNF 2.0) is a software application used on Apple Watch and iPhone that analyzes pulse rate data using machine learning to detect irregular heart rhythms, such as atrial fibrillation (AFib). It notifies users of possible AFib episodes to help prompt medical consultation, supporting non-invasive heart rhythm monitoring through wearable technology.

HealthCCSng is a software device that automatically analyzes non-cardiac-gated CT scans to estimate the amount of calcified plaque in coronary arteries, which can indicate coronary artery disease risk. It provides radiologists with calcium detection categories and annotated images to aid in clinical decision-making within their usual workflow.

FEops HEARTguide is a software tool that helps clinicians simulate and plan the implantation of left atrial appendage occlusion devices in individual patients. By using CT scans to create patient-specific heart models and incorporating device mechanics, it predicts how the device will deform and interact with the tissue, aiding pre-procedural decision-making to improve procedural outcomes and device placement.