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

Korea Biomedical Reviewㅣ 2024-12-17

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.

Clinical trials across Korea, the U.K., Singapore, and the Netherlands have shown promising results, yet one critical gap remains: data from the Hispanic demographic, an absence the FDA has flagged as essential.

“The FDA has made it clear that we need data across all ethnicities. Once we have that, we’re in a strong position,” Rim acknowledged. Mediwhale is already working to fill this gap but faces the challenges of navigating a regulatory process with an approval rate of just 30 percent.

“We’ll get there,” Rim said. “We’re preparing a publication that will not only strengthen our case but open doors for reimbursement in the U.S. healthcare system.” The company aims to submit its application by late 2025, with hopes for a decision by 2026.

If approved, Dr. Noon CVD promises to detect cardiovascular risks early, facilitating preventive care in a country where nearly three-quarters of adults are overweight or obese. Rim highlighted the urgency of tackling cardiovascular-kidney-metabolic syndrome—a condition that links hypertension, diabetes, and dyslipidemia—with innovative solutions.

Beyond approval, Mediwhale faces the challenge of integrating Dr. Noon CVD into primary care. In Korea, fundus cameras—used to photograph the retina—have already facilitated the tool’s adoption in internal medicine clinics. But in the U.S., where more than 1,000 AI-powered devices are already FDA-approved, widespread use of AI tools remains limited.

“Our technology is not just a screening tool,” Rim explained. “We aim to make it both diagnostic and prognostic, embedding it into primary care for accessibility and efficiency.”

Dr. Noon CVD’s anticipated entry into the market comes as AI-driven diagnostic tools are gaining traction. Technologies such as HeartFlow and Lumineticscore have already made inroads into cardiovascular and diabetic retinopathy diagnostics in the U.S.

Rim sees this as an opportunity to carve out a niche. “There’s already momentum in AI retinal screening,” he noted. “Dr. Noon CVD fits perfectly into that pathway.”

The potential market is vast. Recent findings from the National Health and Nutrition Examination Survey reveal that nearly 90 percent of U.S. adults meet the criteria for cardiovascular-kidney-metabolic syndrome, highlighting the need for scalable, preventive solutions.

To expand its reach, Mediwhale has partnered with Dubai-based diabetes clinic GluCare, and it aims to leverage U.S. primary care pathways where retinal cameras are already in use for diabetic retinopathy detection. While competition exists, Mediwhale sees a clear path forward.

Google has been researching AI-based cardiovascular risk prediction since 2016, but remains in the exploratory phase.

Another competitor, Toku Eyes, a New Zealand-born health tech company now based in San Diego, was also vying for a market share with its AI-driven retinal imaging tool, THEIA.

For Mediwhale, the retina’s role as the body’s only accessible window into blood vessels, gives Dr. Noon CVD a critical edge. “The retina provides a unique vantage point,” Rim said. “This insight could be the key to early cardiovascular disease detection.”

The company has already validated Dr. Noon CVD in Korea, where it secured private reimbursement in June 2023. As of August 2024, the tool has been used in over 7,200 cases across 57 medical institutions. However, success in the U.S. hinges on navigating a complex reimbursement landscape.

“Medicare covers those 65 and older, but we’re targeting a younger demographic—people between 45 and 65—the population that needs early intervention,” Rim said. Mediwhale plans to focus its U.S. validation efforts on individuals aged 45 to 75 while preparing to include younger populations in future studies. “Diabetes is rising among younger adults,” Rim said. “Early prevention is critical, and our approach aligns with established cardiovascular disease prevention guidelines.”

In the U.S., AI-based diabetic retinopathy detection costs $47 per screening, with private insurers charging up to $120. Mediwhale anticipates similar pricing for Dr. Noon CVD but recognizes that reimbursement negotiations will be critical.

“If the FDA finds our arguments sound, we’ll secure approval,” Rim said. “Once we achieve U.S. reimbursement, I believe we’ll experience rapid growth. Our ultimate goal is to make Dr. Noon CVD accessible to as many people as possible, so they can use it as part of their daily health monitoring.”

As tech giants explore new approaches like iris scans for cardiovascular predictions, Rim said these approaches remain in their infancy, far from the precision that retinal imaging can offer. Mediwhale is betting on its proven combination of AI, imaging, and non-invasive diagnostics. The company envisions a future where health monitoring is seamlessly integrated into daily life.

“Imagine a world where people can use Apple Watches, (digital) rings, or health stations in convenience stores to monitor their health,” Rim said. “This could prevent the need for clinical intervention before they even become patients.”