[Interview] Mediwhale pushes for FDA approval to bring AI retinal scan to US cardiovascular prevention

November 18, 2024 marked a critical day for Mediwhale, a Korean medical AI company with ambitions to transform cardiovascular disease detection.

The company’s third pre-submission meeting with the U.S. FDA had just concluded, and with it, a feeling of cautious optimism for Dr. Noon CVD—a retinal scan tool designed to assess cardiovascular risk as a non-invasive, cost-effective alternative to CT scans.

“Everything is aligned. The data is solid. Now, we just need to cross the final hurdle,” said Rim Hyung-taek, Mediwhale’s chief medical officer and leader of the FDA De Novo process, in an interview with Korea Biomedical Review 11 days later.