FDA Radiology AI Devices

LVivo Software Application is an AI-powered ultrasound image analysis platform that automatically calculates important medical parameters related to cardiac and bladder function. It helps clinicians assess heart ventricles and bladder volume using processed ultrasound images, thereby improving diagnostic efficiency and accuracy.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing abdominal CT scans to detect suspected Intra-abdominal Free Gas pathologies. It notifies clinicians of positive findings via a desktop application to help prioritize and triage patient workflow, speeding up clinical decision-making while operating alongside standard care without altering original medical images.

qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.

The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems. It uses machine learning (U-Net convolutional neural network) to automatically segment and measure bladder volume from ultrasound images, providing clinicians with noninvasive quantitative data to support diagnosis in adult patients.

MEDO ARIA is a cloud-based medical imaging software that uses machine learning to help clinicians view, quantify, and generate reports from ultrasound images of infant hips. It supports diagnosis of developmental hip dysplasia (DDH) in newborns and infants up to 12 months, assisting radiologists by automating some image analysis tasks and improving workflow efficiency.

QLAB Advanced Quantification Software is a software application that assists clinicians by providing advanced tools to view and quantify ultrasound image data, specifically for cardiac assessment including mitral valve quantification, helping improve diagnosis and treatment planning.

uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

HealthVCF is a software solution that uses artificial intelligence to analyze chest and abdominal CT scans to detect suspected vertebral compression fractures. It helps clinicians prioritize these cases for review within bone health programs by flagging them in a dedicated workstation application without interfering with the standard radiology workflow. The product aims to improve the speed of identifying at-risk patients but does not provide a diagnosis itself.