FDA Radiology AI Devices

EyeBOX is a device that uses an eye-tracking camera and software to measure and analyze eye movements as an aid in assessing concussion within one week of head injury for patients aged 5 to 67. It provides clinicians with a score indicating possible brain injury based on abnormal eye movement patterns, helping supplement traditional neurological assessment.

AmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.

Quantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

vascuCAP is a medical image analysis software designed to help clinicians process and evaluate multidimensional CT images of arterial vessels. It provides tools to visualize vessels in 3D and measure key anatomical features such as lumen boundaries, vessel stenosis, and plaque characteristics. This assists physicians in stratifying patients with atherosclerosis by providing detailed vessel information to complement standard care.

Embrace is a wearable device worn on the wrist that monitors physiological signals such as Electrodermal Activity, motion, and temperature to detect generalized tonic clonic seizures in patients with epilepsy. It helps alert caregivers by sending notifications during seizure events, assisting in timely monitoring and care for patients both at home and in healthcare facilities.

The FFRangio System is an AI-based software device used to analyze standard angiographic images (X-ray based) of coronary arteries. It generates a 3D computer model from these images to simulate blood flow and calculate FFRangio, a measure that helps clinicians assess coronary artery disease functionally. It aids in clinical decision-making by providing detailed physiological information during catheterization procedures without invasive measurements.

Centricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.

FFRct by HeartFlow, Inc. is software that analyzes previously acquired coronary CT images to simulate blood flow and pressure in the coronary arteries. It helps clinicians evaluate coronary artery disease by providing a computer-generated physiological assessment using AI-driven computational models from static CT data.

PowerLook Tomo Detection V2 Software by iCAD Inc. is an AI-based computer-assisted detection and diagnosis tool that helps physicians identify suspicious lesions and calcifications in digital breast tomosynthesis images. It provides confidence scores to assist in evaluating findings, improving radiologist accuracy and reducing reading time during breast cancer screening exams.