Mediwhale
Mediwhale is a Seoul-based medical AI company that develops deep learning software for retinal image analysis to predict cardiovascular and metabolic disease risk, serving hospitals and clinics across 8+ regulatory regions with its flagship Dr. Noon CVD product.
- Company typePrivate
- Founded2016
- HeadquartersSeoul, South Korea
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What Mediwhale does
Mediwhale is a Seoul-based medical AI company founded in October 2016 that develops deep learning software for analyzing retinal fundus photographs to predict cardiovascular and metabolic disease risk. The company's core product, Dr. Noon CVD, is the world's first regulatory-approved AI medical device for cardiovascular disease risk prediction using retinal imaging, demonstrating predictive accuracy comparable to cardiac CT scans without radiation exposure. The technology is built on proprietary deep learning models trained on over 2.1 million clinical data points across diverse populations and imaging devices, validated through 50+ peer-reviewed publications. The product portfolio includes Dr. Noon CVD (cardiovascular risk prediction), Dr. Noon Fundus (automated detection of glaucoma, cataracts, and retinal diseases), and pipeline product Dr. Noon CKD (chronic kidney disease prediction under regulatory review).
The company operates a B2B healthcare software business model, selling AI diagnostic examinations to hospitals, clinics, and health screening centers on a per-test basis (50,000-100,000 KRW per examination in Korea as a non-reimbursable test) supplemented by software licensing through distribution partnerships. Primary go-to-market is direct enterprise sales to major hospitals (Yonsei Severance, Naeun Hospital, Catholic University St. Vincent Hospital) complemented by channel partnerships with Dong-A ST for Korean clinic distribution and Topcon Korea Medical for bundled fundus camera solutions. The platform is commercially deployed across 111-170+ medical institutions in 8+ regulatory regions (Korea, EU CE MDR, UK MHRA, Australia TGA, Singapore HSA, Malaysia, Indonesia, India), with active expansion into Europe (Italy, Poland, Germany, Netherlands, France), Middle East (Dubai via GluCare.Health), Southeast Asia, and the US via FDA De Novo pursuit. The company has raised approximately 51.2 billion KRW (~$38M USD) across multiple funding rounds from 2020 to 2026 and is preparing for a KOSDAQ listing under the technology special track.
Mediwhale firmographics
Firmographics- Name
- Mediwhale
- Legal name
- Mediwhale Inc.
- Website
- https://mediwhale.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Mediwhale is a Seoul-based medical AI company that develops deep learning software for retinal image analysis to predict cardiovascular and metabolic disease risk, serving hospitals and clinics across 8+ regulatory regions with its flagship Dr. Noon CVD product.
- Ownership category
- akta.pro rank
Mediwhale industry classification
Industry- Product category
- Medical AI Diagnostics
- NAICS
- Software Publishers (5132), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)
- akta.pro secondary industries
- Software as a Medical Device (SaMD) – Clinical Decision & Diagnostic Software (HLACANAD), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF), Medical Imaging AI (HDAAAEAH)
Keywords
Where Mediwhale is headquartered
LocationHeadquarters
- HQ city
- Seoul
- HQ country
- South Korea
- HQ region
- Asia
Offices2 records
Markets served
Mediwhale business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Others
Revenue model
- AI Diagnostic Software (Per Test/Examination): Mediwhale generates revenue through the sale of its Dr. Noon AI diagnostic examinations to healthcare institutions. Hospitals and clinics pay for the AI analysis service when conducting retinal scans on patients. In Korea, Dr. Noon CVD is available as a non-reimbursable diagnostic test at 50,000-100,000 KRW per examination. The company is pursuing insurance coverage through the Health Insurance Review and Assessment Service evaluation.
- Software Licensing and Distribution: Revenue generated through distribution partnerships where partners like Dong-A ST and Topcon distribute Dr. Noon solutions to hospitals and clinics across Korea. Partners handle sales and distribution while Mediwhale provides the software.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Dr. Noon CVD examination per session |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels5 records
Mediwhale product offering
Product offeringCore offering
Mediwhale develops and sells AI-powered medical device software that analyzes retinal fundus photographs to predict cardiovascular disease risk and detect eye diseases. Its flagship Dr. Noon platform uses deep learning trained on over 2.1 million clinical data points to deliver non-invasive, radiation-free risk assessments with accuracy comparable to cardiac CT scans.
Product overview
Mediwhale offers a unified platform of retinal AI diagnostic solutions for preventive healthcare. The core product Dr. Noon CVD predicts cardiovascular disease risk through retinal imaging analysis with accuracy comparable to cardiac CT scans. Companion product Dr. Noon Fundus provides automatic detection of eye diseases (glaucoma, cataracts, retinal diseases). Pipeline product Dr. Noon CKD extends the platform to chronic kidney disease prediction. Reti-CVD was the original product name for the cardiovascular risk assessment AI that evolved into Dr. Noon CVD. All products leverage deep learning models trained on over 2.1 million clinical data points across diverse populations and imaging devices.
Differentiator
Problem solved
Functional benefit
Brands
- Dr. Noon CVD: Retina-based AI risk prediction solution that assesses future cardiovascular disease risk using retinal imaging, with accuracy comparable to cardiac CT scans.
- Dr. Noon Fundus
- Dr. Noon CKD
Products and services
- Dr. Noon CVD Retina-based AI software as a medical device that assesses future cardiovascular disease risk by analyzing retinal photographs, with predictive accuracy comparable to cardiac CT scans. Used by hospitals, clinics, and health screening centers for non-invasive, radiation-free CVD risk assessment.
- Dr. Noon Fundus Retina-based AI solution that automatically detects three types of eye diseases—glaucoma, cataracts, and retinal diseases—from a single retinal photograph. Designed for use by ophthalmology clinics and primary care providers.
- Dr. Noon CKD Retinal AI solution for chronic kidney disease prediction, designated as an innovative medical device in Korea. Currently under regulatory review with MFDS for approval.
- Dr. Noon (Europe) Unified retinal AI solution combining eye disease diagnosis and cardiovascular risk prediction, CE MDR certified for commercialization in EU member states.
Quantifiable outcome
- Cardiovascular risk prediction accuracy comparable to cardiac CT (coronary artery calcium scoring)
- +3 more outcomes
Companies that use Mediwhale
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles3 records
Mediwhale technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability3 records
Feature5 records
Mediwhale partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered strategic partner, distribution partner and regional partner.
- Dong-A STstrategic partnerStrategic partnership for distribution of Mediwhale's AI retinal diagnostics across Korea. Following the partnership, adoption across internal medicine clinics increased rapidly with over 40,000 total examinations conducted.
- Topcon Korea Medicaldistribution partnerSupply partnership with Topcon Korea Medical (subsidiary of Revenio Group) for Dr. Noon CVD bundled with Topcon fundus cameras (TRC-NW400) to hospitals and clinics.
- GluCare.Healthregional partnerDubai-based diabetes clinic partnership for Dr. Noon CVD supply and UAE market expansion. Includes collaboration on UAE market entry and Dr. Noon CKD efficacy research.
Scale indicators8 records
Recent moves8 records
Expansion highlights8 records
Mediwhale competitors and assessment
Company assessmentDirect peers
- Eyenuk: Eyenuk develops FDA-cleared AI for retinal image analysis (EyeArt for diabetic retinopathy). Directly comparable retinal AI SaMD vendor with similar regulatory milestones, hospital and clinic deployment model, and clinical screening value proposition.
- AEYE Health: AEYE Health develops AI-based retinal screening for systemic and ocular disease detection, including cardiovascular risk assessment from fundus images. Directly comparable to Mediwhale in technology modality (retinal imaging + deep learning), customer base (primary care and endocrinology), and SaMD regulatory pathway.
- Digital Diagnostics (IDx-DR): Digital Diagnostics pioneered FDA-authorized autonomous AI diagnostics from retinal images (IDx-DR for diabetic retinopathy). A direct peer in retinal AI SaMD with established US regulatory success and similar clinical workflow (primary-care-based screening).
- iHealthScreen: iHealthScreen provides AI-enabled retinal image analysis for systemic disease risk prediction (including cardiovascular), paralleling Mediwhale's Reti-CVD/Dr. Noon CVD approach. Targets similar clinical use cases (asymptomatic screening, metabolic disease management) with comparable regulatory positioning.
Broad incumbents
- Vuno: Vuno is a Korean medical AI company (KOSDAQ-listed) developing deep-learning solutions across multiple imaging and clinical data modalities. Peer in terms of geographic/regulatory context (Korea), target customer (hospitals), and SaMD commercialization model.
- HeartFlow: HeartFlow provides non-invasive coronary CT-derived fractional flow reserve (FFR-CT) for cardiovascular disease diagnosis. Comparable as an established cardiac diagnostics SaMD company targeting similar specialist and primary care prescribers, though HeartFlow's modality (CT) differs from Mediwhale's retinal imaging.
- Cleerly Health: Cleerly applies AI to coronary CT angiography for cardiovascular disease risk assessment. Comparable as an AI-CVD-diagnostics competitor positioning non-invasive imaging as a CT alternative—same end-point (CVD risk prediction) via a different imaging modality, addressing the same clinician and payor stakeholders.
- Lunit: Lunit is a Korean medical AI company listed on KOSDAQ developing deep-learning-based imaging diagnostics, primarily in radiology and mammography. Comparable as a Korean peer medical AI company targeting hospital and screening center customers with regulatory-approved imaging SaMD.
Others
- iCare (Revenio Group): iCare, a Revenio Group subsidiary, manufactures the FDA-cleared DRSplus fundus imaging system and has an exploratory partnership to integrate with Dr. Noon CVD for US market entry. Comparable as an adjacent/imaging ecosystem partner whose commercial hardware footprint anchors Mediwhale's US go-to-market.
- Topcon Healthcare: Topcon is a global manufacturer of fundus cameras and ophthalmic imaging systems, and is Mediwhale's distribution partner in Korea (bundling Dr. Noon with TRC-NW400). Included as a strategic ecosystem partner and adjacent incumbent whose installed base drives Mediwhale's hardware-enabled deployment.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Mediwhale social profiles
Digital presenceMediwhale compliance and trust
Trust signalCompliance2 records
Mediwhale financial estimates
Financial estimateRevenue estimate
Valuation estimate
Mediwhale leadership team
Management profileNumber of profiles
Profiles4 records
Mediwhale subsidiaries and ownership
Company hierarchySubsidiaries1 record
Mediwhale funding detail
Funding detailFunding overview
Funding rounds7 records
Investors19 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Mediwhale M&A and investment
M&A and investmentM&A
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Mediwhale
What does Mediwhale do?
Mediwhale develops and sells AI-powered medical device software that analyzes retinal fundus photographs to predict cardiovascular disease risk and detect eye diseases. Its flagship Dr. Noon platform uses deep learning trained on over 2.1 million clinical data points to deliver non-invasive, radiation-free risk assessments with accuracy comparable to cardiac CT scans.
Is Mediwhale a public or private company?
Mediwhale is a private company. It is classified as venture growth investor backed and is currently operating.
When was Mediwhale founded?
Mediwhale was founded in 2016. It employs 51 to 100 people.
Where is Mediwhale based?
Mediwhale is headquartered in Seoul, South Korea, in the Asia region.
How does Mediwhale make money?
Two revenue lines are on record. AI Diagnostic Software (Per Test/Examination) is the primary driver. The others are software Licensing and Distribution.
Who are Mediwhale's main competitors?
Direct peers on record are Eyenuk, AEYE Health, Digital Diagnostics (IDx-DR) and iHealthScreen. Broad incumbents are Vuno, HeartFlow, Cleerly Health and Lunit. Others are iCare (Revenio Group) and Topcon Healthcare.
Does Mediwhale have an API?
No public API is recorded for Mediwhale.
What industry is Mediwhale in?
Mediwhale's product category is Medical AI Diagnostics. Its primary akta.pro industry code is HLACANAG, SaMD – Imaging & Signal Analysis (AI/ML), with a secondary code of HLACANAD, Software as a Medical Device (SaMD) – Clinical Decision & Diagnostic Software. Its NAICS code is 5132 and its SIC code is 3841.