FDA Radiology AI Devices

The Personalized Physiology Analytics Engine software is a computerized analysis tool designed to monitor changes in a patient's vital signs relationships over time. Using data such as heart rate, respiratory rate, and activity, it calculates a Multivariate Change Index that helps clinicians track significant physiological changes during routine monitoring, aiding in patient assessment but not for direct diagnostic decisions.

The BrainScope Ahead 200 is a portable EEG device designed to aid physicians in evaluating patients with mild traumatic brain injury by measuring and analyzing brain electrical activity. It supports clinical decision-making regarding the need for head CT scans by providing objective quantitative EEG parameters. The device is intended for use as an adjunct to standard clinical practice and includes features such as continuous impedance monitoring and cognitive assessment tools for military use. It helps clinicians by providing rapid brain activity data to support the assessment of brain injury severity without replacing imaging such as CT scans.

The IRIS Intelligent Retinal Imaging System is a web-based software that stores, manages, and displays retinal images and diagnostic data from computerized instruments. It allows licensed clinicians to review fundus images and visual field data to evaluate and diagnose retinal conditions such as diabetic retinopathy, glaucoma, and macular degeneration, thereby assisting in patient care and follow-up.

The BrainScope Ahead 100 is a portable EEG-based device designed to assist physicians in evaluating patients with mild traumatic brain injury. It analyzes brain electrical activity to help decide if a head CT scan is needed, potentially reducing unnecessary CT scans and radiation exposure. The device processes EEG data using AI-driven algorithms to classify patients based on the likelihood of structural brain injury visible on CT.

Quantra is a software application used with digital breast x-ray images to calculate volumetric and area breast density. It aids radiologists by providing quantitative breast tissue composition data to help in consistent breast density reporting. It does not interpret images directly but supports breast cancer risk assessment and reporting.

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.

CVI42 is a software tool designed for analyzing CT and MR images of blood vessels. It provides tools for image visualization, processing, vessel centerline and lumen calculations, stenosis evaluation, and lesion characterization. This helps physicians evaluate and track vascular lesions more effectively for improved patient diagnosis and management.

Hepatic VCAR is a software tool that analyzes CT scans of the liver to help clinicians visualize liver anatomy, detect and measure liver lesions, and assess liver morphology. It provides initial 3D segmentation and vessel analysis with tools allowing users to adjust and confirm segmentation, assisting in clinical review, archiving, and diagnosis related to liver conditions.

YSIO MAX is a modular stationary X-ray imaging system designed for hospitals and clinics. It enables full-body radiographic and tomographic exposures and supports various patient positions. The system includes integrated and portable digital detectors that convert X-rays into diagnostic electronic images. It helps clinicians by offering efficient positioning and image processing, including optional AI-based soft tissue enhancement for chest X-rays, facilitating more accurate and timely diagnosis.

ClearRead +Confirm is a software application that creates enhanced secondary digital chest X-ray images to help healthcare professionals confirm the placement of lines and tubes. This improves visibility on standard chest radiographs, aiding in timely and accurate patient management.