FDA Radiology AI Devices

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.

Autoplaque 3.0 is a post-processing software designed for use with coronary CT angiography images. It helps cardiologists and radiologists analyze coronary arteries to detect and measure plaques and stenosis. The AI-driven software automates vessel, plaque, and lumen segmentation with an option for clinician review, enabling faster and more standardized cardiac image analysis.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

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.

The TruSPECT Radiological Image Processing Station is a nuclear medicine imaging software system designed to process and display SPECT images alongside CT/MR scans for enhanced clinical diagnosis, including attenuation correction and quantitative assessment. It supports AI-based attenuation correction to improve image quality and aids clinicians, particularly for cardiac imaging and other clinical applications, by providing advanced visualization, segmentation, and quantitative tools.

TruPlan is a medical software that helps doctors visualize and measure heart and vessel structures from CT scans to assist in planning the left atrial appendage closure procedure. It provides tools such as segmentation, 3D rendering, and simulated imaging views to support detailed anatomical assessment and device sizing for safe and effective treatment.

Cleerly Labs v2.0 is a web-based software that assists trained medical professionals by analyzing coronary CT images to detect atherosclerosis and stenosis. It uses AI to segment and label coronary arteries, enhancing efficiency and accuracy in diagnosing coronary artery disease and supporting clinical decision making.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

ADAS 3D is a software application designed to help medical professionals visualize and analyze 3D cardiac images obtained from MRI and CT scans. It supports the quantification and visualization of myocardial scar and other cardiac features to assist clinical decision-making for patients with cardiovascular disease. The software enables detailed analysis of the heart's structure and enhancement patterns, facilitating better cardiovascular disease assessment.

Cleerly Labs is a web-based software application that helps trained medical professionals view and analyze cardiac CT images, specifically from Coronary Computed Tomography Angiography (CCTA). It assists in identifying and measuring coronary artery plaques and stenosis to help evaluate coronary artery disease or suspected CAD, providing detailed visualizations and measurements to support clinical decision-making.