Rooti Rx vs ECG Buddy Clinic

The Rooti Rx app is made for medical professionals to be used in conjunction with the Rooti Rx System ECG Event Recorder. Its sole purpose is to set up the FDA registered device. The Rooti Rx app does NOT analyze a patient’s medical condition or display any analysis results or medical advice. When using the app, medical professionals are required to login to their registered account to set up the Rooti Rx System ECG Event Recorder. The Rooti Rx app does not work without login authorization. The Rooti Rx System ECG Event Recorder is not available to everyone. It is only distributed to registered medical professionals for prescribed patient use. Prescribed patients will need to seek a doctor’s advice further before making any medical decisions. FDA 510(k) numbers: K163694 EC Certificate Full Quality Assurance System FI16/07021 TFDA: 005772 ARTG Identifier: 300643

Supports screening of hidden high-risk cardiovascular patients in outpatient care, from a single 12-lead ECG. ECG Buddy Clinic is a Korean MFDS-approved Class III software medical device. Capture a 12-lead ECG with your smartphone, and the AI provides an estimated LVEF and risk scores for 4 digital biomarkers. It reveals possible structural and functional abnormalities beyond standard ECG interpretation, and supports decisions on follow-up tests such as echocardiography or coronary CT. [Estimated LVEF] • Estimated LVEF (%) from the ECG alone • A key reference for identifying heart failure risk and reduced LV systolic function [4 Digital Biomarkers] • CADS: coronary artery disease with ≥50% stenosis • PAF: paroxysmal AF risk from sinus rhythm ECGs • LVH: a major complication of chronic hypertension • HCM: a cause of sudden cardiac death • Risk levels shown at a glance in a graph [Easy to Use] • Automatic ECG area detection on the camera screen • Works with printed ECGs, ECGs on monitors, and saved ECG images • No extra equipment or hospital system integration needed [Validated Technology] • Korean MFDS-approved Class III medical device • Validated in 6 peer-reviewed papers, including Heart Rhythm and European Heart Journal Digital Health • ISO 27001 and ISO 27701 certified [Usage Policy] • Up to 10 analyses per day • Subject to change with prior notice if a subscription is introduced [Precautions] • Please read the "Instructions for Use" before clinical application. • Clinical use is restricted to countries where regulatory approval has been granted (Republic of Korea, Vietnam). For educational and research purposes, use should be limited to post-case reviews and educational interpretations. • For clinical use, this device is intended for physicians capable of interpreting 12-lead ECGs or medical personnel who transmit results to such physicians. • This tool is designed to support diagnostic and treatment decisions and can never replace the professional medical judgment of a physician. *For any inquiries or for more information, please visit our website (www.arpi.ai).