FDA Radiology AI Devices

HealthCXR is a software tool that uses artificial intelligence to analyze adult chest X-ray images for signs of pleural effusion, a condition where fluid accumulates around the lungs. It automatically alerts radiologists by prioritizing critical cases in their worklists, helping them to review urgent scans faster. The software operates alongside the standard care workflow and does not provide a diagnosis on its own, but assists clinicians in managing their caseload more efficiently.

RSI-MRI+ is software designed to assist clinicians by automatically processing diffusion-weighted and anatomical MRI images. It enhances the visibility of restricted diffusion areas, fuses these with anatomical images, and uses AI to segment and quantify the prostate, providing helpful reports. This helps radiologists and urologists more efficiently analyze prostate MRI data.

EchoGo Core is an automated software application that processes echocardiogram images to measure cardiac function parameters such as ejection fraction, global longitudinal strain, and left ventricular volumes. It provides clinicians with quantitative reports to assist in diagnosing heart conditions, improving accuracy and reducing variability compared to manual methods.

MEDIP PRO is a medical imaging software that helps clinicians by processing CT and MRI images. It provides tools for segmenting images, improving image quality, and creating 3D reconstructions that can be exported for 3D printing to aid in preoperative planning. The software is intended to be used alongside other diagnostic tools and clinical judgement to support treatment planning.

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.

KOALA is an automated software that helps medical professionals analyze knee X-rays by measuring joint space width and identifying radiographic signs of osteoarthritis. It assists clinicians in evaluating knee health and aids diagnosis, improving efficiency and accuracy in managing osteoarthritis cases.

The MIMOSA Imager is a cordless, non-contact tissue oximeter that estimates and maps oxygen saturation in superficial tissue. It captures spatially-resolved images using visible and near-infrared light and presents tissue oxygenation as a heat map on a connected Android device. This helps clinicians monitor circulatory or perfusion status in patients, especially for skeletal muscle and suspected compromised circulation.

The RTHawk HeartVista Cardiac Package is an advanced software system that works with 1.5T and 3.0T MRI scanners to acquire and display real-time and conventional cardiovascular magnetic resonance images. It enables clinicians to obtain detailed heart images quickly and accurately, incorporating automated tools to optimize cardiac scans and improve patient imaging workflows.

Merge PACS is a software system that helps medical professionals view, analyze, and manage images from various medical imaging modalities such as CT, MRI, PET, ultrasound, and mammography. It supports diagnostic reading, reporting, and communication workflows, enabling clinicians to efficiently handle patient imaging studies and related data. It includes advanced image manipulation tools and workflow management features to assist radiologists and other medical staff.

The Ventripoint Medical System Plus (VMS+) 3.0 is a software and hardware system that works as an adjunct to ultrasound imaging. It records and analyzes 2D ultrasound images to reconstruct a 3D model of the heart's four chambers, helping clinicians measure heart chamber volumes and ejection fractions. This aids in cardiac assessment by providing detailed and accurate cardiac volume measurements using advanced image analysis techniques.