FDA Radiology AI Devices

Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.

Clarius Prostate AI is an AI-powered ultrasound software tool integrated into the Clarius Ultrasound Scanner system. It assists qualified healthcare professionals by automatically detecting, segmenting, and measuring prostate volume in ultrasound images, helping to streamline clinical workflow and improve prostate assessment accuracy while allowing manual adjustments. It is intended for adult male patients and supports prostate imaging with curvilinear and endo-cavitary scanners.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

Vent Creativity Knee v1.0 (Hermes) is a software tool that processes CT scan images of the knee to segment bones and generate surgical planning data. It uses AI models to accurately identify bone structures and landmarks, aiding clinicians in diagnosis and preoperative planning. The software also supports the creation of physical replicas based on imaging data, facilitating orthopedic applications.

AVIEW is a software product that assists physicians by providing quantitative analysis of CT images for lung and cardiac evaluation. It offers segmentation of lung structures, characterization and measurement of lung nodules, calcium scoring of coronary arteries, and integrates computer-aided detection tools. It can be used both on-premises and in cloud environments, supporting remote access via mobile devices or browsers. This software enhances diagnostic accuracy and aids in patient management by automating complex image analysis tasks.

PeekMed web is an AI-powered software system that helps healthcare professionals perform pre-operative planning for various surgical procedures using patients' imaging studies. It operates in 2D and 3D environments with support for musculoskeletal regions and incorporates automated AI models for bone segmentation and landmarking, improving efficiency and accuracy in surgical planning.

Cleerly LABS (v2.0) is a web-based software tool designed to help trained medical professionals analyze cardiac computed tomography (CT) images from Coronary CT Angiography (CCTA) scans. It uses machine learning to segment and label coronary arteries, assess plaques, stenosis, and vessel measurements, improving the efficiency and accuracy of coronary artery disease (CAD) assessment. The software enhances medical imaging workflows by automating complex, time-consuming tasks while providing interactive 2D and 3D visualizations.

Ceevra Reveal 3+ is a software medical device that processes 3D images from CT and MR scans, employing machine learning to generate segmentations of normal anatomy. It helps healthcare professionals in preoperative surgical planning and intraoperative visualization to improve patient management. The software runs on computers and mobile devices and provides interactive tools for clinicians to examine anatomical structures in detail.

The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.