FDA Radiology AI Devices

Volpara Imaging Software is a tool designed to analyze raw digital mammography and tomosynthesis images to calculate volumetric breast density. It provides quantitative measurements and density maps to assist healthcare professionals in evaluating breast tissue composition. The software operates on a Windows server outside the patient environment and supports clinical decision-making by providing adjunctive information on breast density, aiding in breast cancer screening assessments.

The Zio AT ECG Monitoring System and its ZEUS System component are used for long-term cardiac monitoring by capturing continuous ECG data and analyzing it with AI algorithms to detect arrhythmias. The system helps clinicians by automatically detecting and reporting symptomatic and asymptomatic cardiac events, allowing improved cardiac care and diagnostics.

DenSeeMammo is a software tool designed to assist radiologists by automatically estimating breast density from digital mammography images. It analyzes 2D mammograms and categorizes breast density according to the BI-RADS 5th Edition, providing additional information to aid breast cancer risk assessment. The final breast density assessment remains the responsibility of the qualified physician. This helps clinicians make consistent and informed evaluations of breast density, potentially improving screening and diagnosis.

DM-Density is an AI-based software that processes digital mammogram images to automatically calculate breast density, providing numerical values and breast density grades to assist physicians in assessing breast tissue composition. It supports clinical use by delivering standardized breast density information following BI-RADS classifications, integrating with mammography workstations or PACS.

Quantra is a software tool designed to analyze digital mammographic images and estimate breast tissue composition. It categorizes breast density in a way that aligns with BI-RADS breast composition reporting standards to help radiologists assess breast tissue, aiding consistent reporting for breast cancer screening and diagnosis support, though it is not a diagnostic aid itself.

The CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.

AmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.

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.

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.

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.