Vuno Obtains MFDS Approval for AI Medical Device Detecting Acute Myocardial Infarction

Medical AI company VUNO announced on the 9th that it has obtained medical device approval from the Ministry of Food and Drug Safety for its AI-based acute myocardial infarction detection software, 'VUNO Med-DeepECG™ AMI.' This software-type medical device analyzes electrocardiogram (ECG) data based on AI to detect acute myocardial infarction. It is one of the disease-specific detailed models of VUNO's AI-based ECG analysis software, VUNO Med-DeepECG™, which was designated as an innovative medical device by the Ministry of Food and Drug Safety in 2021.

Acute myocardial infarction (AMI) is a disease in which the coronary artery supplying blood to the heart is suddenly blocked, causing the heart to malfunction, and is one of the leading causes of sudden death. Early detection and response are crucial. Rapid vascular reperfusion procedures after onset to reopen the blocked blood vessels can increase survival rates and minimize sequelae.

Acute myocardial infarction is classified into ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) depending on the presence or absence of ST-segment elevation in ECG data. STEMI occurs when the coronary artery supplying blood to the heart is completely closed, causing severe chest pain and other symptoms. NSTEMI involves partial occlusion of the coronary artery accompanied by various symptoms, but it is characterized by the difficulty of detection even by specialists’ interpretation due to the lack of distinct features in ECG data.

VUNO Med-DeepECG™ AMI analyzes ECG data to detect both STEMI and NSTEMI with high accuracy and indicates the presence or absence of acute myocardial infarction. Its excellent performance was also demonstrated in clinical trials involving patients with acute myocardial infarction. This product is expected to contribute to early screening of emergency patients requiring rapid action in hospitals and to improve patient prognosis within the golden time.

VUNO plans to link the home-use ECG measurement medical device Hartiv P30 with VUNO Med-DeepECG™ AMI. This will help patients detect acute myocardial infarction in daily life and receive timely appropriate medical treatment. It is expected to help protect patient safety and reduce regional medical disparities in medically underserved areas with low medical accessibility and a shortage of medical personnel.

Lee Yeha, CEO of VUNO, said, "Through this approval, we have been able to introduce an AI medical device that can detect acute myocardial infarction, which has a high initial mortality rate and severe sequelae even after recovery, in advance and enable timely treatment. We will continue research and development and business on various diseases that can be identified through ECG data to consistently introduce products that can protect patient safety not only in hospitals but also at home."