FDA Radiology AI Devices

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 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.

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.

The physIQ Heart Rhythm and Respiration Module is a software device that analyzes ECG signals and movement data to calculate heart rate, heart rate variability, detect atrial fibrillation, and determine respiration rate. It helps clinicians remotely monitor cardiac and respiratory health in adult patients outside of critical care settings, enhancing patient care through advanced signal processing and automated analysis.

The Loop System by Spry Health, Inc. is a prescription-only wearable device designed for adult patients to collect physiological data such as oxygen saturation, heart rate, and respiration rate during resting periods. It passively records data using reflectance-based photoplethysmography from the wrist and uploads the information to a server for remote clinician review, aiding in patient monitoring in home environments.

KardiaAI is a software library by AliveCor that analyzes ambulatory ECG rhythms to identify heart conditions such as atrial fibrillation, bradycardia, and tachycardia. It supports integration into other ECG devices and helps clinicians by providing automated ECG noise filtering, heart rate measurement, and rhythm classification to inform diagnosis and monitoring.

RhythmAnalytics is a software tool that analyzes single-lead ECG data to detect cardiac arrhythmias and measure heart-related signals. It helps healthcare professionals by providing supportive interpretations and can be integrated with other devices or platforms to assist clinicians in diagnosing heart rhythm disorders.

The Study Watch by Verily Life Sciences LLC is a wearable ECG monitoring device that records and securely transmits single-channel ECG waveforms. It assists healthcare professionals in tracking heart rhythms of adult patients with known or suspected heart conditions by enabling remote ECG data collection and review via a web portal.