South Korea authorizes VUNO’s personal ECG machine


Medical AI company VUNO has received clearance from South Korea’s Ministry of Food and Drug Safety for its personal ECG device.

Called Hativ Pro, the wearable medical device simply measures a user’s heart rate and sends that data through a connected mobile phone app.


VUNO offers a range of medical AI solutions for doctors and healthcare institutions. Following this latest government certification, VUNO can finally move towards offering AI medical devices to consumers.

With clearance from the MFDS, the company plans to soon launch its integrated health management brand Hativ, which includes AI-powered home medical devices that support everyday consumer health management and diagnosis. early 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 every year due to the aging population.

“Through our medical AI project based on ECG data, 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 home-based AI medical devices to detect major heart diseases.


In recent months, VUNO has garnered several regulatory approvals to commercialize its AI medical solutions in South Korea and the rest of Asia-Pacific.

In March, VUNO obtained approval from the South Korean government for VUNO Med LungQuant, an AI-based lung CT quantification solution for the accurate assessment and screening of lung diseases. Last year, he also received MFDS authorization for VUNO Med DeepCARS, a medical device that uses AI to analyze a person’s risk of cardiac arrest.

During the first half of the year, the company also obtained market approvals in Thailand, Saudi Arabia and Malaysia for its other VUNO Med offerings.


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