FDA Radiology AI Devices

Accipiolx is an artificial intelligence software tool designed to automatically analyze non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It integrates into hospital radiology networks to prioritize cases suggesting hemorrhage, enabling quicker review by clinicians and faster treatment decisions in acute care settings.

BriefCase is an AI-powered software that assists radiologists by analyzing non-enhanced head CT images to detect suspected intracranial hemorrhages. It provides timely notifications with preview images to prioritize cases for faster review, helping clinicians improve workflow efficiency and patient care without altering original images or making diagnoses.

Viz CTP is a software package that processes and analyzes CT perfusion scans of the brain to calculate parameters related to tissue blood flow and volume. It helps clinicians by providing detailed brain perfusion maps that assist in diagnosing and managing neurological conditions, improving clinical decision-making.

Quantib Brain is a software application that automatically labels, visualizes, and measures brain structures and white matter lesions on MRI scans. It helps trained medical professionals by providing quantitative information to assist in the evaluation and assessment of brain MR images, supporting more informed and quantitative reporting in clinical settings.

cNeuro cMRI is a software tool designed to automatically identify, label, quantify, and visualize brain structures from MRI scans. It helps medical professionals by automating manual processes in brain image analysis, improving efficiency in the assessment of brain volumes and abnormalities compared to a healthy reference population.

NeuroQuant is an AI-powered software tool that automatically processes MRI brain scans to identify and measure various brain structures and lesions. It generates detailed visual and quantitative reports, helping clinicians by automating the manual work of brain segmentation and volume measurement, thus supporting diagnosis and monitoring of neurological conditions.

EnsoSleep is a software tool that uses AI algorithms to analyze sleep study data, including brain waves and breathing patterns, to help physicians evaluate sleep quality and diagnose sleep-related disorders such as sleep apnea. It automates scoring of sleep stages, detection of arousals, leg movements, and breathing events, improving efficiency while requiring clinician verification.

SIS Software is designed to help medical professionals such as surgeons, neurologists, and radiologists visualize and plan surgeries targeting brain structures, particularly the subthalamic nucleus. It uses machine learning and image processing to enhance standard MRI images and create patient-specific 3D models of brain anatomy, supporting safer and more precise stereotactic surgical procedures.

Quantib Brain 1.2 is a software tool that assists radiologists by automatically identifying and measuring different brain structures and white matter abnormalities from MRI scans. It provides visualizations and quantitative data to support evaluation and reporting, enabling better assessment of brain health over time by comparing multiple scans of the same patient.

CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.