FDA Radiology AI Devices

The LVivo Software Application is a medical software that analyzes echocardiographic ultrasound videos to automatically detect and measure the left ventricular wall and function of the heart. It helps clinicians assess cardiac function by calculating metrics like ejection fraction and myocardial strain, thus aiding in cardiac diagnosis and management.

Quantib Brain 1 is an AI-powered software tool that automatically labels and measures the volumes of brain structures from MRI scans. It helps radiologists by providing quantitative data and visualization of brain tissue and white matter abnormalities to support diagnosis and reporting.

Volpara Imaging Software is a medical imaging application designed to analyze digital mammography and tomosynthesis images. It generates detailed breast density maps and calculates volumetric breast density, helping healthcare professionals assess breast tissue composition. The software provides numerical breast density values and BI-RADS categories as adjunctive information, supporting the diagnostic process.

AlphaPoint Imaging Software is a tool that helps clinicians review and analyze CT chest images by providing segmentation and numerical analysis of tissue types. It assists in identifying different substances in the images and generates preliminary reports to support medical decision-making.