9月2日 的 ECG Buddy Clinic 應用程式分析

Capture 12-lead ECGs with your smartphone camera and assess your patients’ heart health! ECG Buddy Clinic is a Class III software medical device approved by the Korean Ministry of Food and Drug Safety (MFDS). It analyzes 12-lead ECG images from adult patients to estimate left ventricular (LV) systolic function and to assess the risk of coronary artery disease, paroxysmal atrial fibrillation, left ventricular hypertrophy, and hypertrophic cardiomyopathy. It is a separate product from ECG Buddy, specifically focused on screening and health check-ups. 5 digital biomarkers · Assessment of heart failure risk by estimating left ventricular ejection fraction (LVEF) · Screening for clinically significant coronary artery disease ( 50% stenosis,≥ CAOD) · Screening for paroxysmal atrial fibrillation (Paroxysmal AF, PAF) · Assessment of left ventricular hypertrophy (LVH) risk · Screening for hypertrophic cardiomyopathy (HCM) Easy clinical adoption · Capture printed ECGs or ECGs displayed on a monitor as they are · ECG images saved in the photo gallery or posted on websites can also be analyzed Usage policy (credits) · Currently: up to 10 analyses per day are available. · This policy may change in the future with the introduction of a subscription system, with prior notice. Precautions · Before use, be sure to read the Instructions for Use and use the product only within the approved indications. · Clinical use is permitted only in countries where this product is approved. (For educational or research purposes, use should be limited to retrospective case review and educational interpretation.) · For clinical use, this product is intended only for physicians who can interpret 12-lead ECGs, or healthcare professionals who transmit the analysis results to such physicians. · ECG Buddy Clinic is a tool that supports heart health assessment and must never replace a physician’s clinical judgment regarding diagnosis or treatment. · If there are any questions about a patient’s health status, a medical professional should always be consulted. This product is a medical device software approved for diagnostic support purposes. The responsibility for the final diagnosis lies with the user (physician). Medical device regulatory coverage: Republic of Korea Other regions: Available for research use only and outside the scope of medical device regulations (Research Use Only)