FDA Radiology AI Devices

StrokeViewer Perfusion is a software package designed to analyze dynamic brain CT perfusion scans to provide quantitative information about blood flow and volume in brain tissue. It aids medical professionals by visualizing perfusion maps and numerical data to assist in the evaluation of suspected ischemic stroke patients. The software supports clinicians by generating additional imaging data to inform diagnosis and treatment decisions without replacing clinical judgment.

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

Momentum Spine is a mobile application that uses a smartphone camera to capture a 3D model of the torso and applies artificial intelligence to measure and track postural asymmetries, including scoliosis. It assists clinicians and patients in monitoring spinal health by providing quantitative assessments such as predicted Cobb angle and asymmetry metrics, enhancing early detection and management of spinal deformities.

Cleerly ISCHEMIA is an AI-based software tool that analyzes coronary CT angiography images to help clinicians detect likely ischemia in coronary vessels. It works as an add-on to Cleerly Labs software, providing a non-invasive decision support tool to assess the functional significance of coronary artery disease, aiding patient management alongside traditional diagnostic methods.

Brainomix 360 e-ASPECTS is an AI-powered software that analyzes non-contrast CT brain scans to assist clinicians in detecting and characterizing ischemic brain tissue injuries, particularly in cases of acute stroke caused by MCA or ICA occlusions. It automatically provides an ASPECTS score, highlights affected brain regions, and visualizes voxel contributions to the score, helping clinicians make timely and more accurate assessments to guide stroke treatment.

MR Diffusion Perfusion Mismatch V1.0 by Olea Medical is an AI-powered software tool that automatically processes MR Diffusion and Perfusion imaging data to compute parametric maps, extract volume metrics, and calculate mismatch volumes. It assists radiologists and surgeons by providing quantitative imaging data that supports clinical decision-making. The software integrates with medical image platforms to streamline workflow without altering the original images and is intended to be used alongside other clinical information, not as a standalone diagnostic tool.

BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.

BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.

The Atrial Fibrillation History Feature is a software application designed to analyze pulse rate data from Apple Watch sensors to detect episodes of irregular heart rhythm indicative of atrial fibrillation (AFib). It provides users with estimates of the amount of time spent in AFib over past periods and visualizes this alongside lifestyle data to help users understand the impact of their behavior on their condition. It assists patients in monitoring AFib burden over time but is not meant to replace traditional diagnosis or treatment methods.

Rapid is a medical image processing software that helps clinicians visualize and analyze tissue changes in CT and MRI images, particularly aiding in the selection of acute stroke patients for treatment. It uses AI/ML components to detect image artifacts and supports advanced imaging features such as perfusion, diffusion and dynamic contrast analysis.