FDA Radiology AI Devices

VBrain-OAR is a software device from Vysioneer Inc. designed to assist trained radiotherapy personnel in brain tumor radiation therapy treatment planning by automatically generating contours of organs at risk in brain MRI images using AI deep learning. It also provides image registration functions to align multi-modality medical images. This device supports clinicians by providing initial contour outlines to improve the efficiency and consistency of radiation treatment planning, while still requiring final confirmation by qualified personnel.

InferRead CT Stroke.AI is an AI-powered software that helps hospitals and radiologists prioritize head CT scans by flagging suspected intracranial hemorrhage cases. It analyzes CT images using a deep learning algorithm and highlights potential emergency cases on a worklist, assisting clinicians in faster triage. The software operates alongside standard radiology workflows without altering images or removing cases, improving efficiency in detecting brain hemorrhages.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

HALO is an AI-powered notification software that analyzes brain CT angiograms to detect signs of suspected intracranial Large Vessel Occlusion (LVO). It helps clinicians by promptly notifying appropriate medical specialists to facilitate quicker evaluation and treatment of stroke patients, improving emergency care and patient outcomes.

Automatic Anatomy Recognition (AAR) is a software medical device that uses deep learning to automatically identify and contour anatomical structures from CT scans. It is designed to assist technicians and physicians in radiation therapy planning by providing precise contours of organs at risk in the head, neck, and chest areas. This helps improve the accuracy and efficiency of treatment planning for patients undergoing radiation therapy for cancers in these body regions.

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.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

VBrain is an AI-powered software device that helps trained medical professionals by automatically generating initial contours of known brain tumors on MRI scans. It supports radiation therapy planning by providing preliminary tumor outlines for professionals to review and adjust, streamlining the clinical workflow for brain tumor treatment planning.

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.