FDA Radiology AI Devices

Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.

The Ventripoint Medical System Plus (VMS+) is an advanced ultrasound image analysis device that works alongside existing ultrasound systems. It digitally records and processes 3D ultrasound images to help clinicians evaluate the volumes and functions of the heart's left and right ventricles as well as the left and right atria. This aids in detailed cardiac assessment, providing valuable information on heart chamber sizes and function, which supports diagnosis and management of cardiac conditions.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.

The LVivo Software Application is a medical software that analyzes echocardiographic ultrasound videos to automatically detect and measure the left ventricular wall and function of the heart. It helps clinicians assess cardiac function by calculating metrics like ejection fraction and myocardial strain, thus aiding in cardiac diagnosis and management.