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.

IDx-DR is an AI-based retinal diagnostic software designed to automatically detect more than mild diabetic retinopathy in adults with diabetes using retinal fundus images acquired with a specific fundus camera. It helps clinicians by providing screening results that indicate the presence or absence of disease, enabling timely referral and treatment to prevent vision loss.

The Acumen Hypotension Prediction Index (HPI) Feature Software is a clinical decision support tool that uses arterial blood pressure waveform data and patient demographics to predict the likelihood that a patient will experience hypotension within 15 minutes. It provides clinicians real-time, adjunctive physiological insights to help anticipate and manage hypotensive events in operating room patients with advanced hemodynamic monitoring.

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.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.

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.