FDA Radiology AI Devices

The Cardiac CT Function Software Application by Circle Cardiovascular Imaging is a software tool that assists medical professionals in analyzing cardiac function from multi-phase, multi-slice cardiovascular CT angiography images. It uses AI to segment cardiac structures and compute key function metrics such as volume and ejection fraction, helping clinicians evaluate heart function more accurately and efficiently.

LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.

InVision Precision LVEF is a software tool that analyzes previously acquired transthoracic cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, helping clinicians with cardiac evaluation. The software processes DICOM ultrasound videos, uses machine learning to segment the left ventricle, and allows clinicians to review and adjust the measurements for precise cardiac function assessment.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that include innovative AI-powered software features. The Smart View Select software automatically selects optimal heart images for analysis, while the Segmental Wall Motion software evaluates the movement of specific regions of the heart's left ventricle. These tools help clinicians perform more efficient and precise cardiac assessments, enhancing diagnosis and treatment planning.

The CorVista System with PH Add-On is a non-invasive AI-based medical device that analyzes sensor-acquired cardiac electrical and hemodynamic signals to indicate the likelihood of elevated pulmonary arterial pressure, aiding clinicians in diagnosing pulmonary hypertension. It provides results through a user-friendly digital interface and supports healthcare providers by combining the AI output with clinical judgment.

Us2.v2 is software that processes cardiac ultrasound images to automatically measure various heart structures and functions, helping clinicians analyze echocardiograms more efficiently and accurately. It supports qualified healthcare professionals by providing automated measurements of cardiac size and function, improving workflow and aiding diagnosis in adult patients.

AVIEW CAC is a software that analyzes non-contrast chest CT scans to quantify calcified plaques in coronary arteries, calculate the Agatston score, and provide risk stratification based on calcium scoring, age, and gender. It helps radiologists and cardiologists by supporting image storage, transfer, and display, facilitating clinical decision-making for coronary artery disease risk assessment.

Eko Low Ejection Fraction Tool (ELEFT) is an AI-based software device that analyzes ECG and heart sound recordings to help clinicians identify patients with reduced left ventricular ejection fraction (LVEF ≤ 40%), a marker of potential heart failure. It is intended for use on adults at risk of heart failure and supports referral decisions for further testing like echocardiography, without replacing diagnostic procedures.

inHEART Models is a suite of medical imaging software tools designed to assist physicians, cardiologists, and radiologists by automatically processing CT images to create 3D models of the heart. It uses AI for automatic segmentation and visualization, helping clinicians better interpret cardiac anatomy for diagnosis and treatment planning.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound machines designed for diagnostic imaging and fluid flow analysis of the human body. They include a new AI-powered Smart Doppler View ID feature that automatically navigates and selects the appropriate Doppler measurement groups on the touchscreen interface, enhancing clinician workflow and reducing manual navigation during cardiac ultrasound exams. This helps clinicians focus on key Doppler measurements efficiently during cardiac assessments.