VitalRhythm
VitalConnect, Inc.VitalRhythm is a cloud-based AI software that continuously analyzes ECG signals to detect various cardiac arrhythmias. It works with a wearable biosensor (VitalPatch) and displays results to healthcare professionals for non-urgent clinical decision-making in outpatient and non-critical care settings. It helps clinicians monitor heart rhythms remotely and efficiently, assisting in diagnosis without replacing clinical judgment.
Intended Use
VitalRhythm is a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch biosensor, intended for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making in adults 18 years or older.
Technology
VitalRhythm is a cloud-based software utilizing a proprietary deep learning-based algorithm to analyze single-lead ECG and RR-interval data transmitted securely via the VitalPatch biosensor and Vista Solution platform. The system displays detected arrhythmias for review by qualified healthcare professionals through the VistaCenter web application.
Performance
Performance testing used a large retrospective ECG dataset from over 3,309 patients and demonstrated sensitivity, specificity, PPV, NPV, and accuracy exceeding 95% for detection of major arrhythmias such as atrial fibrillation, AV block, supraventricular tachycardia, ventricular tachycardia, and pauses. Sinus rhythm detections met acceptance criteria of ≥90%. No additional clinical testing was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/22/2024
8 months - 2
FDA Approval
4/17/2025
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