FDA Radiology AI Devices

AI4CMR v1.0 is a software tool that uses artificial intelligence to automatically analyze cardiac MRI scans to measure cardiac function parameters like ventricle volumes and ejection fraction. It helps clinicians by providing automated quantification of cardiac metrics from MR images, improving workflow efficiency and supporting clinical decisions when integrated into a DICOM viewer.

Libby Echo:Prio is a software tool that processes DICOM-compliant cardiac ultrasound images to provide automated measurements and analysis of cardiac function, such as ejection fraction and heart rate. It supports cardiologists and sonographers by automating view classification, border segmentation, and generating quantification reports, thus aiding clinical decision-making in cardiac care.

The Study Watch with Irregular Pulse Monitor by Verily Life Sciences is a wearable device designed for adults diagnosed with or at risk for atrial fibrillation (AF). It continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel ECG measurements. The device notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review. This aids early detection and monitoring of AF, enabling timely clinical intervention.

The ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation in adult patients.

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 iq is a high-performance compact diagnostic ultrasound system designed for cardiovascular and shared service imaging. It assists healthcare professionals in ultrasound imaging, measurement, display, and analysis of human body and fluid, across a wide range of clinical applications including fetal, cardiac, abdominal, musculoskeletal, and vascular imaging. It incorporates advanced ultrasound modes such as Doppler, color Doppler, harmonic imaging, and real-time 3D imaging, supporting various transducers and enabling flexible clinical use in hospital and office environments.

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.