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.

The ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation in adult patients.

The Eko Murmur Analysis Software (EMAS) is a cloud-based AI-driven tool that analyzes heart sound and ECG data to detect and classify heart murmurs, distinguishing between innocent and structural murmurs. It supports clinicians by offering decision support in evaluating heart sounds, enhancing the diagnostic process for pediatric and adult patients without replacing clinical judgment.

The Atrial Fibrillation History Feature is a software application designed to analyze pulse rate data from Apple Watch sensors to detect episodes of irregular heart rhythm indicative of atrial fibrillation (AFib). It provides users with estimates of the amount of time spent in AFib over past periods and visualizes this alongside lifestyle data to help users understand the impact of their behavior on their condition. It assists patients in monitoring AFib burden over time but is not meant to replace traditional diagnosis or treatment methods.

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.

The AHI System is a software tool that helps healthcare professionals monitor adult patients' cardiovascular status by analyzing ECG signals to detect signs of current hemodynamic instability and predict future episodes. It provides continuous updates and color-coded alerts for clinicians to increase vigilance and improve patient care.

IM007 by Implicity, Inc. is an AI-powered software that analyzes ECG data from Insertable Cardiac Monitors to help healthcare professionals detect various cardiac arrhythmias, such as atrial fibrillation and ventricular tachycardia. It works by processing ECG signals remotely uploaded from compatible devices and provides analysis results to clinicians to support diagnosis and patient monitoring.

The Analytic for Hemodynamic Instability (AHI) is a software device that analyzes ECG signals to monitor patients' hemodynamic status, detecting signs of instability defined by low blood pressure combined with high heart rate. It provides clinicians with frequent, updated alerts to increase vigilance for patients at risk of hemodynamic deterioration, serving as an adjunctive monitoring tool alongside other patient data to improve early detection and patient management in clinical settings.

The VX1 is a cardiac mapping software tool designed to assist clinicians during atrial fibrillation or atrial tachycardia procedures by analyzing 3D anatomical and electrical maps of the heart's atria. Using machine and deep learning algorithms, it identifies complex dispersed electrograms in real-time to help guide electrophysiologists in annotating areas of interest, potentially improving mapping accuracy during catheter ablation procedures.

AI-ECG Tracker is software designed to assist healthcare professionals in hospitals by automatically analyzing ambulatory ECG data to detect and assess cardiac arrhythmias in adults. It processes ECG waveforms, detects specific ECG features like QRS complexes and ectopic beats, measures intervals and heart rate, and provides advisory interpretations to support clinical diagnosis of arrhythmias, but not as the sole diagnostic tool.