FDA Radiology AI Devices

HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.

DEEPVESSEL FFR is a clinical software tool that uses deep learning to analyze previously acquired coronary CT angiography (CTA) images. It generates three-dimensional models of coronary artery trees and estimates fractional flow reserve (FFR) values to help clinicians assess the functional severity of coronary artery disease. It supports doctors by providing additional insight beyond anatomical imaging, using AI-based physiological simulation to improve diagnosis and treatment planning for heart vessel conditions.

HeartFlow FFRct Analysis is a software tool that uses AI to analyze previously acquired coronary CT images (CT DICOM data). It creates a 3D computer model of the coronary arteries and simulates blood flow and pressure to help clinicians evaluate coronary artery disease. This aids in diagnosis and treatment planning by providing functional insights beyond traditional imaging.