FDA Radiology AI Devices

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

BrainSee is software that helps clinicians predict whether patients aged 55 to 95 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer's disease dementia within 5 years. It uses standard brain MRI scans along with patient demographics and cognitive test scores to generate a similarity score indicating the likelihood of progression. This tool provides supplemental prognostic information to aid clinical decision-making but is not a standalone diagnostic device.

The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.

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.