FDA Radiology AI Devices

Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.

ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.

CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.

The Clarius Ultrasound System is a portable ultrasound imaging device that wirelessly connects to smartphones or tablets, allowing medical professionals to perform real-time ultrasound scans for various clinical applications such as emergency triage, procedure guidance, fetal imaging, and musculoskeletal assessment. It supports multiple probes and is designed for use by trained healthcare providers in clinical settings.

The Ahead 300 is a portable, non-invasive medical device that records and analyzes brain electrical activity to assist clinicians in evaluating patients with closed head injuries. It provides algorithm-based classifications of structural brain injury and measures brain function and cognitive performance to support diagnosis and treatment decisions, particularly to aid in deciding on the necessity of head CT scans.

PixelShine is a software application that improves the quality of CT images by reducing noise, making them clearer to assist radiologists and specialists in diagnosing patients. It connects to existing CT imaging systems, processes the images, and sends enhanced images back for review, facilitating better clinical decisions.

ClearRead CT is a software application that helps radiologists detect lung nodules in chest CT scans by providing enhanced image processing with vessel suppression and computer-aided marking. This assists radiologists in identifying potential nodules more effectively and efficiently during their review, improving diagnostic accuracy and workflow.

HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.

Icobrain is a software that automatically identifies and measures volumes of brain structures in MRI scans. It helps clinicians by automating the manual process of labeling and quantifying brain regions, supports analysis at single or multiple time points, and generates detailed reports with volumetric measures to assist in diagnosis and tracking of neurological conditions.

The Triton System is a medical software application designed to assist surgical teams by estimating the amount of blood loss on used surgical sponges through image analysis. It runs on an iPad and uses validated hardware and software to calculate hemoglobin mass and blood volume, helping clinicians manage bleeding and surgical sponges more effectively during operations.