FDA Radiology AI Devices

LiverSmart is a software that automatically analyzes MRI images of the liver to measure both liver iron concentration and liver fat content. It processes images according to established protocols and generates a comprehensive report that assists clinicians in diagnosing and monitoring liver conditions such as iron overload and fatty liver disease, supporting treatment decisions and research.

BoneMRI is a software application that enhances MRI images to improve visualization of bone structures in the pelvic region, including the sacrum, hip bones, and femoral heads. It processes 3D MRI scans using a convolutional neural network algorithm to create enhanced images that help radiologists and orthopedic surgeons in assessing bone morphology and radiodensity without needing CT scans.

qXR-BT by Qure.ai Technologies is an AI-powered software designed to analyze chest X-ray images to help physicians confirm the position of breathing tubes. It generates secondary digital images with highlighted tube tips and anatomical landmarks, providing valuable adjunctive information during radiological assessment.

BU-CAD is a software application designed to assist physicians by analyzing breast ultrasound images to identify and evaluate soft tissue lesions suspicious for breast cancer. It highlights regions of interest and provides malignancy scores and BI-RADS classifications to support clinical decision-making. It also supports viewing of mammography images and includes tools for image adjustment and documentation, helping improve diagnostic accuracy and efficiency.

EchoGo Core (2.0) is an AI-powered software that analyzes ultrasound images of the heart (echocardiograms) to automatically quantify and report cardiac function metrics. It assists physicians by providing measurements like ejection fraction, ventricular volume, and strain, helping in cardiovascular diagnosis for adult patients.

Koios DS is a web-based AI software that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules suspicious for cancer. It automatically selects regions of interest, classifies lesions using standardized lexicons like BI-RADS and TI-RADS, provides cancer risk assessments, and generates structured reports to aid in clinical decision-making, improving diagnostic accuracy and reducing variability.

VBrain is a software tool that helps medical professionals in planning radiation therapy for brain tumors. It uses artificial intelligence, specifically deep learning neural networks, to automatically outline brain tumors and organs at risk on MRI scans of the brain. This assists clinicians by providing initial contours that they can review and adjust, improving workflow efficiency and accuracy in treatment planning.

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.

RT-Mind-AI is a software tool designed to automatically segment organs-at-risk in non-contrast CT images for patients undergoing radiation therapy. It helps radiation oncologists by providing accurate anatomical contours that support treatment planning and evaluation, improving workflow and precision.

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.