FDA Radiology AI Devices

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.

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.

TeraRecon Neuro is an AI-powered image processing software that analyzes brain perfusion data from CT or MRI scans. It helps healthcare professionals visualize blood flow and other key parameters in the brain to aid diagnosis, treatment planning, and post-treatment evaluation by providing detailed parametric maps and 3D visualizations of brain tissues and vessels.

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.

Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.

SwiftMR is a software medical device designed to automatically enhance brain MRI images by reducing noise and improving image sharpness. It processes MRI scans in DICOM format using advanced deep learning models, helping radiology professionals obtain clearer images for better diagnosis and clinical decision-making without interrupting their workflow.

The SIS System (Version 5.1.0) is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures such as the subthalamic nuclei and globus pallidus from MRI and CT scans. It uses advanced deep learning models to create 3D anatomical models to aid in stereotactic surgical planning and lead placement, improving visualization and accuracy during procedures.

BrainInsight is a software tool designed to analyze low-field MRI brain scans automatically. It uses machine learning to segment brain structures, measure volumes, and provide annotated images and reports to assist clinicians in evaluating brain anatomy quickly and efficiently.

CorInsights MRI is an automated software that processes brain MRI scans to identify and measure brain structures. It helps clinicians by providing detailed volumetric reports comparing patient brain volumes to normal reference data, aiding in research and clinical assessment of neurologic conditions in adults 45 to 95 years old.

The Neuro.AI Algorithm by TeraRecon, Inc. is an AI-powered medical imaging software that analyzes brain perfusion images acquired via CT or MRI. It processes dynamic imaging data to generate detailed maps of brain tissue blood flow and vascular structures, helping trained medical professionals assess brain perfusion and vascular health efficiently. The software outputs detailed parametric maps and visualization aids to support clinical diagnosis without replacing physician judgment.