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.

The MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit are MRI systems designed to produce detailed cross-sectional images and spectroscopic data of the head, body, and extremities. They support advanced imaging workflows and reconstruction frameworks, helping clinicians diagnose medical conditions by providing clear internal images and physical parameters. The system can also assist in interventional procedures with MR-compatible devices.

LiverMultiScan v5 is software that helps clinicians assess liver health by analyzing MRI scans to generate detailed images and quantitative maps of liver tissue properties such as fat content, iron concentration, and T1 relaxation times. It aids doctors in diagnosis by providing automated liver segmentation and measurements that enhance non-invasive liver assessment.

MRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.

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.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.

AI4CMR v1.0 is a software tool that uses artificial intelligence to automatically analyze cardiac MRI scans to measure cardiac function parameters like ventricle volumes and ejection fraction. It helps clinicians by providing automated quantification of cardiac metrics from MR images, improving workflow efficiency and supporting clinical decisions when integrated into a DICOM viewer.

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.

ProstatID is an AI software tool designed to assist radiologists by analyzing prostate MRI scans to identify and assess suspicious lesions that may indicate prostate cancer. It processes MRI images and provides detection overlays, lesion likelihood scores, 3D renderings, and a summary report to support diagnostic decisions for high-risk screening or diagnostic imaging.

The MAGNETOM Free.Max and MAGNETOM Free.Star are advanced magnetic resonance imaging (MRI) systems designed by Siemens. These devices produce detailed cross-sectional images of the body to help clinicians visualize internal structures and diagnose various conditions. Featuring new software and hardware enhancements, they provide improved imaging workflows, patient comfort with different bore sizes, and automated shoulder examination support, aiding physicians in accurate diagnosis and patient management.