FDA Radiology AI Devices

HepaFat-AI is an AI-powered software that automatically analyzes MRI images of the liver to measure liver fat content. It helps clinicians assess fatty liver disease, monitor liver fat in patients undergoing weight loss, and screen liver transplant donors by providing quantitative and reproducible fat fraction results quickly without manual input.

LiverMultiScan (LMSv4) is a standalone software device that assists clinicians by processing MR images of the liver to provide quantitative maps and measurements that help characterize liver tissue health. It automates segmentation and analysis of MRI data to produce reports for trained clinicians to interpret as part of liver disease diagnosis and assessment.

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.

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.

Hepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.

LiverMultiScan (LMSv3) is a software tool that helps clinicians analyze liver MRI scans. It produces detailed images and quantitative maps of liver tissue properties such as fat content, iron levels, and T1 relaxation times to assist in non-invasive liver evaluation. This software aids trained operators in generating reports that help medical professionals diagnose liver diseases more accurately and efficiently.

MRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.

FerriSmart is a medical software that automatically analyzes MRI scans of the liver to measure iron concentration. This helps doctors diagnose and monitor patients with iron overload diseases, such as thalassemia or sickle cell disease, making treatment decisions more accurate and timely.

The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.

The BladderScan Prime PLUS System is a non-invasive ultrasound device that measures the volume of urine in the bladder using patented neural network technology. It assists clinicians by providing real-time bladder volume measurements and directional aiming feedback to improve patient management and care.