Medical AI company VUNO has received the South Korean Ministry of Food and Drug Safety’s clearance for its personal ECG device.
Called Hativ Pro, the portable medical device simply measures a user’s heart rate and sends this data through a connected mobile phone app.
WHY IT MATTERS
VUNO has been offering a range of medical AI solutions for doctors and health facilities. Following this latest government certification, VUNO can finally move towards offering AI medical devices to consumers.
With the MFDS clearance, the company plans to soon launch its integrated health management brand Hativ, featuring AI-powered home medical devices that support consumers’ daily health management and early diagnosis of chronic diseases.
VUNO continues to strengthen its medical AI business based on ECG data, which the company claims have “high potential as a biomarker for various cardiovascular diseases”. In South Korea, CVDs are the second leading cause of death after cancer with cases rising each year due to an ageing population.
“Through our ECG data-based medical AI project, we will do our best to reduce mortality from cardiovascular disease and contribute to preventive treatment – the future direction of medical care,” said VUNO CEO Lee Ye Ha.
In the future, VUNO plans to release more home AI medical devices for detecting major heart diseases.
THE LARGER TREND
In recent months, VUNO has been collecting several regulatory approvals to market its AI medical solutions in South Korea and the rest of Asia-Pacific.
In March, VUNO secured the South Korean government’s approval for VUNO Med LungQuant, an AI-based lung CT quantification solution for the precise evaluation and screening of lung diseases. Last year, it also received an MFDS clearance for VUNO Med DeepCARS, a medical device that uses AI to analyse a person’s risk for cardiac arrest.
In the first half of the year, the company also obtained market approvals in Thailand, Saudi Arabia, and Malaysia for its other VUNO Med offerings.