Mediwhale’s Retinal-AI “Dr. Noon CVD” Surpasses 100 Medical Institutions Worldwide, Driving Global Expansion Ahead of FDA Approval
Mediwhale, the AI-powered health diagnostics company, announced that its flagship solution Dr. Noon CVD has been adopted by more than 111 medical institutions worldwide, surpassing the 100-site milestone just two years after launch.
Following a strategic partnership earlier this year with Dong-A ST, a leading South Korean pharmaceutical company, adoption across internal medicine clinics has rapidly increased, with over 40,000 total examinations conducted to date.
Dr. Noon CVD is the world’s first AI solution capable of predicting future cardiovascular disease risk through a simple retinal scan, achieving accuracy comparable to cardiac CT. The solution is recognized for its superior accessibility and efficiency compared to conventional tests such as cardiac CT and carotid ultrasound, and is now expanding across hospitals and clinics in Korea, Europe, and the Middle East.
This year, Mediwhale gained significant global recognition, with more than 10 research abstracts accepted and invited presentations at leading international cardiology conferences, including the European Society of Cardiology (ESC), American Heart Association (AHA), and American Society for Preventive Cardiology (ASPC). These studies validated that retinal AI can accurately evaluate cardiovascular, renal, and metabolic function, signaling a transformative shift in preventive healthcare.
Looking ahead, Mediwhale is targeting FDA De Novo approval for Dr. Noon CVD in 2026, while also preparing to launch Dr. Noon CKD, a retinal AI solution for chronic kidney disease prediction, in the Korean market. Designated as an innovative medical device, Dr. Noon CKD is currently undergoing confirmatory clinical trials for Ministry of Food and Drug Safety (MFDS) approval.
“Mediwhale’s rapid growth across more than 100 medical institutions reflects the market’s strong confidence in our product. With our upcoming U.S. FDA submission and the launch of Dr. Noon CKD, we are accelerating our global expansion to redefine preventive care and drive sustainable revenue growth.”said Taegun Choi, CEO of Mediwhale.
About Mediwhale
Mediwhale is transforming preventive healthcare through AI-powered retinal imaging, enabling early detection of systemic diseases from a simple eye exam. The company’s flagship product Dr. Noon CVD uses advanced deep learning to analyze retinal photographs and predict risks of cardiovascular disease with accuracy comparable to cardiac CT scan. Learn more about how Mediwhale is redefining preventive care at mediwhale.com.
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