CardioSleeve

Regulatory information The CardioSleeve System has U.S. FDA clearance under 510(k) K131287 for its specified intended use. The United States is the jurisdiction of FDA clearance. Use outside the United States is subject to applicable local regulatory requirements. Intended users and medical disclaimer CardioSleeve is intended for trained healthcare personnel in clinical settings. Results require physician review together with other relevant patient information. It does not provide an independent diagnosis or replace clinical judgment. Seek a doctor’s advice in addition to using this app and before making any medical decisions. The CardioSleeve app is the first FDA cleared stethoscope add-on system for clinicians to acquire 3-Lead ECG and Digital Heart Sound at any point of care. CardioSleeve enhances the traditional stethoscope by recording, displaying and analyzing the heart's ECG and acoustical footprints, synchronized, in real time via any wirelessly connected portable device. CardioSleeve assists clinicians in: Visualizing Heart Murmur The CardioSleeve app enhances a stethoscope by providing synchronized Digital Auscultation with ECG; allowing for visualized heart sound and Murmur Detection. Analyzing Heart Rhythm The CardioSleeve stethoscope attachment records High-Fidelity 3- Lead ECG tracings with a digital caliper to be viewed and analyzed on a connected device.