A software as a medical device analyzes 12-lead ECG data using artificial intelligence to indicate the likelihood of acute myocardial infarction with scores and risk assessment.
[What is MI?]
Acute myocardial infarction is a disease in which the coronary arteries that supply blood to the heart are acutely blocked by thrombosis or rapid contraction of blood vessels, and heart muscle tissue is necrotic due to failure to provide oxygen and nutrition to the heart.
[User Benefit]
- Diagnosing myocardial infarction with just a 12-lead ECG
- Low, intermediate, high: 3 levels of risk severity, consistent with international clinical guidelines
- Early triage, Early screening : for ECG judged as 'low risk,' there were zero actual acute myocardial infarction (AMI) patients (negative predictive value 100%), whereas for ECG judged as 'high risk,' out of 335 actual AMI patients, 189 were correctly identified (positive predictive value 56.4%).
- AUROC of 91.7% in confirmatory clinical trials
- Can be used immediately in conjunction with compatible ECG machines
[Others]
- Korea gov. declared reimbursement for AiTiALVSD(Jan 29, 2024)
- 45th Breakthrough Device from KFDA(Nov 8, 2023)