Mediwhale, a Korean medical AI company, is advancing its efforts to secure FDA approval for Dr. Noon CVD, an AI-driven retinal scan designed to detect cardiovascular risk. The company recently concluded its third pre-submission meeting with the FDA, expressing optimism about the potential of this non-invasive and cost-effective alternative to CT scans.
Addressing Unmet Needs in Cardiovascular Disease Detection
Rim Hyung-taek, Mediwhale’s chief medical officer, emphasized the significance of Dr. Noon CVD, stating, "Dr. Noon CVD isn’t just about screening—it’s about prevention. If we succeed, we could change how the world manages cardiovascular disease." The tool aims to address the urgent need for early detection and preventive care, particularly in light of the rising prevalence of cardiovascular-kidney-metabolic syndrome, which links hypertension, diabetes, and dyslipidemia.
Clinical Validation and Remaining Hurdles
Clinical trials conducted across Korea, the U.K., Singapore, and the Netherlands have yielded promising results. However, the FDA has identified a critical gap: the absence of data from the Hispanic demographic. "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 actively working to address this requirement, navigating a regulatory landscape where the approval rate is only 30 percent.
Integration into Primary Care and Market Potential
Mediwhale plans to submit its FDA application by late 2025, with hopes for a decision by 2026. The company aims to integrate Dr. Noon CVD into primary care settings, leveraging the existing infrastructure of fundus cameras used for diabetic retinopathy detection. In the U.S., where nearly 90 percent of adults meet the criteria for cardiovascular-kidney-metabolic syndrome, the potential market for scalable, preventive solutions is vast.
Competitive Landscape and Future Vision
While companies like HeartFlow and Lumineticscore have already introduced AI-driven diagnostic tools for cardiovascular and diabetic retinopathy, Mediwhale sees an opportunity to carve out a niche. Rim highlighted the unique advantage of retinal imaging, stating, "The retina provides a unique vantage point. This insight could be the key to early cardiovascular disease detection." Mediwhale has already secured private reimbursement for Dr. Noon CVD in Korea, where it has been used in over 7,200 cases across 57 medical institutions. The company envisions a future where non-invasive health monitoring tools are seamlessly integrated into daily life, enabling early disease prevention.
Reimbursement Strategy and Target Population
Mediwhale is focusing its U.S. validation efforts on individuals aged 45 to 75, recognizing the need for early intervention in this demographic. While Medicare covers individuals 65 and older, Mediwhale aims to target the younger population at risk. The company anticipates similar pricing to existing AI-based diabetic retinopathy detection, which costs $47 per screening, with private insurers charging up to $120. Securing U.S. reimbursement will be critical for the widespread adoption of Dr. Noon CVD.
