FDA Radiology AI Devices

The Vivid T8 and Vivid T9 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also supporting vascular and general radiology applications. They provide digital acquisition, processing, analysis, and image display, and incorporate AI algorithms such as Easy Auto EF and Easy AFI LV that assist clinicians by automating measurements and analysis of cardiac function, improving workflow and diagnostic accuracy.

The Vivid S60N and Vivid S70N are advanced, general-purpose ultrasound systems specialized for cardiac imaging, but also supporting multiple other clinical applications such as abdominal, vascular, and musculoskeletal imaging. They provide digital ultrasound image acquisition, processing, analysis, and display with various transducer options and imaging modes. The systems include AI-powered features like Easy Auto EF and Easy AFI LV for automated cardiac function assessment to assist clinicians in evaluating heart health efficiently.

The Eko Murmur Analysis Software (EMAS) is a cloud-based AI-driven tool that analyzes heart sound and ECG data to detect and classify heart murmurs, distinguishing between innocent and structural murmurs. It supports clinicians by offering decision support in evaluating heart sounds, enhancing the diagnostic process for pediatric and adult patients without replacing clinical judgment.

The Atrial Fibrillation History Feature is a software application designed to analyze pulse rate data from Apple Watch sensors to detect episodes of irregular heart rhythm indicative of atrial fibrillation (AFib). It provides users with estimates of the amount of time spent in AFib over past periods and visualizes this alongside lifestyle data to help users understand the impact of their behavior on their condition. It assists patients in monitoring AFib burden over time but is not meant to replace traditional diagnosis or treatment methods.

The syngo.CT CaScoring software by Siemens is used to analyze non-contrast cardiac CT scans to detect and evaluate calcified lesions in coronary arteries. It calculates scores like the Agatston score, mass, and volume scores for different coronary arteries, helping physicians assess coronary artery disease and generate detailed reports to support patient management.

DEEPVESSEL FFR is a clinical software tool that uses deep learning to analyze previously acquired coronary CT angiography (CTA) images. It generates three-dimensional models of coronary artery trees and estimates fractional flow reserve (FFR) values to help clinicians assess the functional severity of coronary artery disease. It supports doctors by providing additional insight beyond anatomical imaging, using AI-based physiological simulation to improve diagnosis and treatment planning for heart vessel conditions.

Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.

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.