Mediwhale 'Doctor Noon'... Selected as a New Medical Technology with Evaluation Postponed

Mediwhale announced on the 13th that its cardiovascular risk assessment software ‘Dr. Noon (Reti-CVD)’, which predicts cardiovascular risk based on retinal image artificial intelligence (AI) analysis, has met the requirements in terms of target users, purpose, and safety, and has been confirmed as a conditional new medical technology with evaluation deferral.

Cardiovascular Risk Assessment Software Medical Device (SaMD) 'Doctor Noon' by Mediwhale
[Photo by Mediwhale]

The new medical technology evaluation considers not only the safety, efficacy, and cost-effectiveness of the technology but also the social, ethical, and legal impacts caused by the technology. The Korea Health Industry Development Institute supports the entry of outstanding and highly potential medical technologies into the medical market as non-reimbursable services through the conditional new medical technology evaluation system.

With this selection, Mediwhale’s Dr. Noon has received approval for clinical use for about three years, including a two-year evaluation deferral and up to 250 days of new medical technology evaluation, allowing it to be prescribed as a non-reimbursable service in medical settings. Based on clinical data accumulated during the deferral period, the final evaluation will determine reimbursement status through the Health Insurance Review and Assessment Service.

Dr. Noon is an AI medical device that predicts cardiovascular disease with accuracy equivalent to cardiac computed tomography (CT) through retinal imaging. It can provide test results within one minute from retinal imaging and overcomes the radiation exposure issues of cardiac CT and the accessibility limitations in primary care settings, making it expected to have significant medical impact when utilized in clinical practice, including primary care institutions.

Previously, Dr. Noon demonstrated efficacy equivalent to cardiac CT using data from 220,000 retinal images of patients worldwide, and was published in international medical journals such as The Lancet Digital Health. It received approval from the Ministry of Food and Drug Safety in August last year. It has been approved in eight regions including Europe, the UK, and Australia, and is currently undergoing approval procedures with the U.S. Food and Drug Administration (FDA).

Choi Tae-geun, CEO of Mediwhale, said, “With this selection as a conditional new medical technology, Dr. Noon has become the first AI test that can be billed as a non-reimbursable service in outpatient clinics. We will strive further to enable many patients worldwide to conveniently and accurately predict cardiovascular risk beyond Korea.”