FDA Radiology AI Devices

Rapid ASPECTS is an AI-powered software that helps doctors analyze CT brain scans to detect and score early signs of ischemic stroke by automatically segmenting brain regions and calculating an ASPECTS score. This aids clinicians in timely and accurate diagnosis, improving stroke assessment especially when expert radiologists are not immediately available.

CINA is an AI-based software that assists radiologists by analyzing head CT scans and CT angiographies to flag suspected cases of intracranial hemorrhage and large vessel occlusion. It provides timely notifications with preview images to help prioritize cases for quicker evaluation, improving workflow and patient care without altering original images or making direct diagnoses.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.

qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.

NinesAI is a software tool that uses artificial intelligence to automatically analyze head CT images for signs of intracranial hemorrhage and mass effect. It helps prioritize critical cases by notifying radiologists of potential emergencies to assist in timely and effective patient care. The software works alongside standard workflows and does not replace full clinical evaluation or diagnosis.

CuraRad-ICH is an AI-powered software that helps radiologists quickly identify and prioritize head CT scans that may show acute intracranial hemorrhage (bleeding in the brain). By automatically analyzing CT images, it assists in faster diagnosis and treatment decisions to improve patient outcomes.

Rapid ICH is an AI-powered clinical software tool designed to help hospital radiology workflows by automatically analyzing non-contrast head CT scans to detect suspected intracranial hemorrhage. It provides alerts and compressed preview images to clinicians through PACS, email, and a mobile app to prioritize urgent cases and aid timely diagnosis and treatment decisions.

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

icobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.