FDA Radiology AI Devices

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.

DASI Dimensions (V1.0) is a clinical decision support software that processes multiphase CTA chest images to generate automated measurements of cardiovascular structures. It helps cardiologists and radiologists by providing detailed images and numerical data to support planning for aortic valve replacement procedures, improving accuracy and efficiency of pre-operative assessments.

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.

The 6440 MyLabX90 by Esaote is an advanced multifunctional ultrasound scanner that supports real-time imaging and analysis during diagnostic ultrasound procedures. It integrates AI features like automated endocardial border detection for cardiac function assessment and lesion contouring for breast exams, helping clinicians improve diagnostic accuracy and efficiency across multiple body regions.