Medical AI company VUNO has received approval from South Korea’s Ministry of Food and Drug Safety for its personal ECG machine.
Called the Hativ Pro, the wearable medical device simply measures a user’s heart rate and sends that data through a connected mobile phone app.
WHY IT MATTERS
VUNO offers a range of medical AI solutions for doctors and healthcare institutions. After this latest government certification, VUNO can finally move on to offering AI medical devices to consumers.
With the MFDS clearance, the company plans to soon launch its integrated health management brand, Hativ, which includes AI-powered home-use medical devices that support consumers’ daily health management and early detection of chronic diseases.
VUNO continues to strengthen its medical AI business based on ECG data, which the company says has “high potential as a biomarker for various cardiovascular diseases.” In South Korea, cardiovascular disease is the second leading cause of death after cancer, with cases increasing each year due to an aging population.
“Through our ECG data-based medical AI project, we will do our best to reduce cardiovascular disease mortality and contribute to preventive treatment – the future direction of medical care,” said Lee Ye Ha, CEO by VUNO.
In the future, VUNO plans to launch more AI medical devices for home use to detect severe heart disease.
THE BIGGER TREND
In recent months, VUNO has secured multiple regulatory approvals to commercialize its medical AI solutions in South Korea and the rest of the Asia-Pacific region.
In March, VUNO secured South Korean government approval for VUNO Med LungQuant, an AI-based lung CT quantification solution for precise assessment and screening of lung diseases. Last year it also received an MFDS clearance for VUNO Med DeepCARS, a medical device that uses AI to analyze a person’s risk of cardiac arrest.
In the first half of the year, the company also received marketing approvals in Thailand, Saudi Arabia and Malaysia for its other VUNO Med offerings.