FDA Radiology AI Devices

BriefCase by Aidoc Medical, Ltd. is an AI-powered radiological software that helps radiologists quickly identify head CTA images with suspected Large Vessel Occlusion. It provides notifications and compressed preview images in parallel to standard image interpretation to speed triage and prioritization, enhancing clinical workflow without replacing full diagnostic review.

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

Transpara is an AI-powered software designed to assist radiologists in detecting and diagnosing breast cancer from screening mammograms. It highlights suspicious soft tissue lesions and calcifications and provides likelihood scores for cancer presence, helping clinicians make more informed decisions during mammogram interpretation.

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.

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.

ProFound AI Software V2.1 is an AI-based software designed to assist radiologists in detecting soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It highlights suspicious breast lesions by marking areas in the images and assigns confidence scores to help physicians identify likely malignant regions, supporting earlier and more accurate breast cancer diagnosis.

aBSI is a software-only medical device designed to quantitatively assess and analyze skeletal disease burden on bone scans from nuclear medicine imaging. It helps healthcare professionals by automatically detecting and quantifying lesions to support clinical decision-making, particularly in oncology, by measuring disease extent in the skeleton.

DeepCT is an AI software tool that analyzes non-contrast CT brain images in acute settings to detect signs of intracranial hemorrhage. It sends notifications to specialists to prioritize and review cases quickly, improving workflow and potentially speeding patient care. It supports, but does not replace, radiologists' diagnostic process.

The CLARUS 700 by Carl Zeiss Meditec, Inc. is a high-resolution ophthalmic imaging device used for capturing and analyzing images of the retina and ocular structures. It supports multiple imaging modes including true color, autofluorescence, and fluorescein angiography, aiding clinicians in diagnosing and monitoring retinal diseases by providing widefield and ultra-widefield views with AI assistance for optic nerve detection and montage creation. The device improves patient comfort and provides advanced tools for image annotation and review.

Bone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.