'Predicting Cardiovascular Disease with AI Eye Examination' Mediwhale Obtains Health New Technology Certification

AI medical device startup Mediwhale announced on the 11th that it has obtained the Health New Technology (NET) certification designated by the Ministry of Health and Welfare.

Choi Tae-geun, CEO of Mediwhale (right), is receiving the Health New Technology (NET) certification from Kim Dong-seok, Director of the Korea Health Industry Development Institute, at the Health Industry Innovation Startup Center in Jung-gu, Seoul, on the 8th.
[Photo by Mediwhale]

The Health New Technology NET certification is a system in which the Ministry of Health and Welfare evaluates the technological excellence and commercialization potential of newly developed health technologies in Korea and grants certification. The Ministry, together with the Korea Health Industry Development Institute, conducts evaluations across seven fields including medical science, biotechnology, pharmaceuticals, medical devices, food hygiene, cosmetics, and traditional Korean medicine. Certified technologies can use the NET mark for up to five years and receive benefits such as additional points when applying for government support projects, priority purchase requests for new technology products by the Public Procurement Service, and technology finance support from national financial institutions.

Mediwhale received the certification on the 8th for its AI technology that analyzes fundus images to assess coronary artery calcification. This technology is used in ‘Doctor Noon’ (English name Reti-CVD), the world’s first AI medical device cardiovascular risk assessment software that predicts the risk of cardiovascular disease using retinal photographs.

The coronary artery calcification index is the most accurate indicator for predicting future cardiovascular risk. However, it can only be measured by cardiac computed tomography (CT), which limits accessibility and involves several constraints such as radiation risk and cumbersome procedures. In particular, it has not been introduced in local clinics frequently visited by patients with diabetes, hypertension, hyperlipidemia, and obesity, so many people have not benefited from it.

Doctor Noon is a software medical device (SaMD) that predicts future cardiovascular disease risk by analyzing the vascular structure in the retina using AI from a simple eye photograph. Doctor Noon maintains performance equivalent to predictions using cardiac CT but can be used easily and quickly without radiation risk, overcoming the limitations of existing tests. This was reaffirmed through the recent Health New Technology certification.

Choi Tae-geun, CEO of Mediwhale, stated, “Doctor Noon, an AI test that predicts cardiovascular disease through the retina, is a highly accurate and accessible test that can currently be performed at local clinics, and the Ministry of Health and Welfare has recognized this through the Health New Technology and conditional new medical technology evaluations.” He added, “Cardiovascular disease is a life-threatening issue for the continuously increasing number of patients with diabetes, obesity, and hypertension, so accurately assessing their cardiovascular risk is essential for prevention.” He continued, “As the first medical AI test eligible for non-reimbursed prescriptions, we will strive to ensure it is widely used in actual medical settings along with ongoing research.”