South Korean startup VUNO has announced that its artificial intelligence (AI)-based fundus reading solution VUNO Med Fundus AI has obtained medical device certification from the Health Sciences Authority (HSA) in Singapore.

HSA certification is a system in which all medical devices manufactured, imported or sold in Singapore are reviewed and certified by the Medical Device Regulatory Authority under the Ministry of Health of Singapore.

The Singapore medical device market is expected to reach $1 billion by 2024, growing at a CAGR of 8.7% from 2019 to 2024. 

Vuno Med Fundus AI is the first artificial intelligence medical device developed in Korea to help with fundus diagnosis, and was designated as the first innovative medical device in Korea by the Ministry of Food and Drug Safety in July 2020.

Yeha Lee, CEO of Vuno , said, “With the acquisition of Singapore HSA certification, Vuno’s AI solution, which has proven clinical effectiveness in various medical fields, will be able to enter the Singapore market, which has established itself as a hub of the Southeast Asian medical industry . We will continue to focus on strengthening our overseas business based on successive acquisitions of overseas licenses for major medical imaging products such as Malaysia, Thailand and Saudi Arabia .”