FDA Radiology AI Devices

NS-HGlio is a software tool that assists clinicians in analyzing MRI images of patients with high-grade brain gliomas by automatically labeling and measuring tumor regions. It supports doctors by providing volumetric data and visual overlays to help monitor tumor progression or treatment response, but it is not intended for primary diagnosis.

ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.

BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.

AI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

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.