FDA Radiology AI Devices

The Study Watch by Verily Life Sciences LLC is a wearable ECG monitoring device that records and securely transmits single-channel ECG waveforms. It assists healthcare professionals in tracking heart rhythms of adult patients with known or suspected heart conditions by enabling remote ECG data collection and review via a web portal.

The FFRangio System is an AI-based software device used to analyze standard angiographic images (X-ray based) of coronary arteries. It generates a 3D computer model from these images to simulate blood flow and calculate FFRangio, a measure that helps clinicians assess coronary artery disease functionally. It aids in clinical decision-making by providing detailed physiological information during catheterization procedures without invasive measurements.

FFRct by HeartFlow, Inc. is software that analyzes previously acquired coronary CT images to simulate blood flow and pressure in the coronary arteries. It helps clinicians evaluate coronary artery disease by providing a computer-generated physiological assessment using AI-driven computational models from static CT data.

The AI-ECG Platform by Shenzhen Carewell Electronics is an AI-powered software that assists healthcare professionals in measuring and interpreting 12-lead resting electrocardiograms (ECGs). It automatically analyzes ECG data, provides diagnostic interpretations for common cardiac abnormalities, and enables physicians to review and modify results. This helps clinicians make more informed cardiac assessments in hospitals and healthcare facilities.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also support other applications such as fetal, abdominal, pediatric, vascular, and musculoskeletal imaging. These systems use ultrasound technology to produce detailed real-time images, including 3D and 4D imaging, helping clinicians diagnose and monitor various conditions effectively. The devices also feature enhanced workflow tools, advanced imaging options, and support comprehensive networking and data sharing capabilities, improving the efficiency and accuracy of ultrasound examinations.

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.

The Zio AT ECG Monitoring System and its ZEUS System component are used for long-term cardiac monitoring by capturing continuous ECG data and analyzing it with AI algorithms to detect arrhythmias. The system helps clinicians by automatically detecting and reporting symptomatic and asymptomatic cardiac events, allowing improved cardiac care and diagnostics.

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.