FDA Radiology AI Devices

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.

HALO is a cloud-based artificial intelligence software that helps medical specialists by analyzing brain CT angiograms to detect signs of large vessel occlusion, a serious condition associated with stroke. It runs alongside the standard imaging workflow and sends alerts to specialists to expedite patient evaluation and care, improving stroke diagnosis and treatment speed.

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.

FastStroke, CT Perfusion 4D is a software package designed to aid clinicians in analyzing and visualizing CT scans, especially for stroke assessment. It processes and displays vascular and perfusion data from CT scans of the head and neck to help identify collateral vessels and perfusion abnormalities, assisting physicians in stroke evaluation and treatment planning.

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.

THINQ is a medical imaging software device designed to automatically segment, label, and measure volumes of brain structures from 3D T1-weighted MRI scans. It provides clinicians with visual and quantitative reports comparing brain volumes to reference data, helping in the assessment of neurological conditions by automating brain morphometry.

AccipioIx is an AI-based software that processes non-contrast head CT scans to identify signs of acute intracranial hemorrhage. It helps clinicians prioritize urgent cases for faster review by analyzing images and flagging suspected hemorrhages, improving workflow efficiency in acute care settings.

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.