FDA Radiology AI Devices

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.

Rapid SDH is an AI-based software that helps radiologists prioritize and triage head CT scans by detecting suspected hemispheric subdural hemorrhage (SDH). It analyzes non-contrast head CT images in parallel with standard readings and provides timely notifications with preview images for informational use, assisting clinicians in workflow management to improve patient care.

AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.

Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable, ultra-low field MR imaging device designed to produce images of the internal structures of the head. It uses deep learning algorithms to improve image quality by reducing noise and blurring, helping clinicians at the point of care obtain diagnostic information even when full diagnostic exams are impractical.

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.

The EFAI NeuroSuite CT ICH Assessment System by Ever Fortune.AI is AI-based software that analyzes adult non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It helps radiologists prioritize urgent cases by sending triage notifications to their imaging workstations, enabling faster clinical assessment. This tool supports but does not replace clinician review.

Brainomix 360 Triage LVO is an AI-powered software that analyzes CT angiogram images to detect suspected large vessel occlusions in the brain. It assists hospital clinicians by providing priority notifications and compressed image previews via a mobile app or web interface, helping specialists quickly identify and review critical cases in parallel with standard workflows. This tool supports faster triage but is not intended for diagnostic use on its own.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

Annalise Enterprise CTB Triage Trauma is an AI software tool designed to analyze non-contrast brain CT scans and assist clinicians by prioritizing cases with features suggestive of mass effect. It integrates with image and order management systems to notify users for earlier review, improving workflow efficiency without replacing clinical decision-making.