FDA Radiology AI Devices

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.

JLK-ICH is an AI-powered software that analyzes non-contrast CT scans of the head to detect suspected intracranial hemorrhage. It provides automated notifications to clinicians to prioritize review, allowing faster communication and potentially improving patient outcomes. The software works alongside standard care without replacing diagnostic evaluations.

The NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.

SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.

CDM Insights is a software tool that helps trained healthcare practitioners analyze brain MRI scans of adults over 45 years old. It automatically segments and quantifies brain structures and white matter hyperintensities, compares findings with normative data from healthy populations, and provides easy-to-understand visual and numerical reports. This aids clinicians in evaluating neurological conditions more accurately and efficiently.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.