FDA Radiology AI Devices

RUS by Hutom Inc. is a medical imaging software designed to aid healthcare professionals in reading, interpreting, and planning treatment based on iodine contrast-enhanced abdominal CT scans. The software provides basic imaging tools, 3D modeling, and segmentation of anatomical structures, including organs and vessels, enhancing surgical planning and diagnosis. It incorporates AI-based machine learning models to improve accuracy in organ segmentation, vessel detection, and pneumoperitoneum analysis, supporting clinicians in patient management decisions.

SubtleSYNTH (1.x) is an AI-based software that synthesizes STIR contrast images from T1- and T2-weighted spine MRI sequences. It uses a convolutional neural network to generate synthetic images that can be reviewed alongside traditional MRI scans, helping radiologists by providing additional image contrast information without additional scanning time or patient burden.

The SKOUT system is a medical software device that uses artificial intelligence to assist gastroenterologists in real-time detection of potential colorectal polyps during colonoscopy procedures. It provides visual markers on the endoscopic video feed to highlight suspected polyps, helping doctors identify these abnormalities more effectively during colorectal cancer screening or surveillance.

BriefCase-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.

The SKOUT system is a computer-aided detection software designed to assist gastroenterologists during colonoscopy by identifying potential colorectal polyps in real time. It highlights suspected polyps on endoscopic video to aid in colorectal cancer screening or surveillance, supporting clinicians in making more accurate evaluations.

VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.

The iCAS-LV software from HighRAD Ltd. is an advanced image analysis tool that helps physicians visualize and evaluate liver lesions in CT scans. It uses interactive segmentation, automatic registration, and volume measurement to track lesions' size, shape, and changes over time, supporting clinical decision-making without replacing physician judgment.

HealthFLD is an AI-powered software that analyzes CT images of the liver to provide clinicians with quantitative and qualitative measurements of liver attenuation, aiding the assessment of fatty liver disease. It processes both non-contrast and contrast CT scans for adult patients and outputs liver density metrics to support clinical decision-making.

The GI Genius system by Cosmo Artificial Intelligence is an AI-powered tool that helps doctors detect colonic mucosal lesions, such as polyps and adenomas, in real time during routine white-light endoscopy exams. It enhances lesion detection by analyzing live endoscopy video and highlighting areas of interest on the gastrointestinal tract on the display, supporting clinicians in making accurate diagnoses during colonoscopy procedures.

The EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.