FDA Radiology AI Devices

HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.

HeartFlow FFRct is a software tool that analyzes existing CT images of coronary arteries to calculate fractional flow reserve (FFRCT). This helps clinicians assess the functional significance of coronary artery disease non-invasively, aiding diagnosis and treatment decisions without requiring additional imaging or radiation.

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.