FDA Radiology AI Devices

The Withings Scan Monitor 2.0 is a smart scale device that records a two-channel electrocardiogram (ECG) when a user stands on it and holds a handle. It analyzes the ECG data using AI algorithms to detect normal rhythms and atrial fibrillation, and displays results on the device and a mobile app, helping patients and clinicians monitor heart conditions conveniently at home or clinical settings.

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 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 CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.