FDA Radiology AI Devices

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

HeartFlow Analysis is a medical software that uses previously acquired coronary CT images to create 3D models and simulate blood flow dynamics in coronary arteries. It helps clinicians assess coronary artery disease by providing detailed functional information derived mathematically from CT scans, supporting diagnosis and treatment planning in stable symptomatic patients.

The Stethee Pro 1 is an electronic stethoscope designed for medical screening and diagnostic use. It detects and amplifies sounds from the heart, lungs, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. This helps clinicians better assess patient heart and lung conditions through enhanced audio and data analysis tools.

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.

The Study Watch with Irregular Pulse Monitor is a wearable device that records, stores, and transmits single-channel ECG rhythms to help detect irregular pulses such as atrial fibrillation in adults. It uses proprietary electrodes and PPG sensors to collect physiological data, which can be reviewed by healthcare professionals via a web portal to support diagnosis and patient monitoring.

The FFRangio System is a software tool that analyzes previously acquired angiographic images using 3D computer modeling to simulate blood flow in coronary arteries. It provides a mathematically derived value to support the functional assessment of coronary artery disease, helping clinicians evaluate artery physiology and make informed treatment decisions.

The Zio XT and Zio AT ECG Monitoring Systems by iRhythm Technologies, Inc. analyze continuous ECG data collected via wearable patches and generate detailed reports on cardiac events. These systems help clinicians diagnose heart rhythm abnormalities by providing comprehensive, beat-to-beat ECG analysis over long monitoring periods for patients with or without symptoms.

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.

Biovitals Analytics Engine is a cloud-based software that analyzes continuous biometric data from sensors measuring heart rate, respiratory rate, and activity in ambulatory patients. It creates a personalized biometric signature for each patient and computes a Biovitals Index to track changes in vital signs over time, providing clinicians with additional insight for routine monitoring without replacing traditional vital sign monitoring.