VUNO | AI Medical Software Manufacturer & Biosignal Solutions

VUNO | AI Medical Software Manufacturer & Biosignal Solutions

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Company Profile

VUNO Inc. is a South Korea-based manufacturer of    AI-powered medical diagnostic software, headquartered in    Seoul, South Korea. Founded in    2014 by CEO Lee Yeha and co-founders, the company operates as a    publicly listed entity on    the Korea Exchange KOSDAQ (338220) with    152 employees,    serving global medical AI markets with products deployed in over    80 hospitals across Korea and expanding into    Europe, the Middle East, and the Americas.

Core Products & Technologies

AI Medical Imaging Solutions

VUNO Med-DeepBrain: FDA-cleared AI brain quantification software analyzing MRI to detect neurodegenerative diseases including Alzheimer's before mild cognitive impairment
   • VUNO Med-Chest X-ray: AI diagnostic support system for pulmonary abnormalities integrated with Samsung Electronics GM85 mobile X-ray
   • VUNO Med-Fundus AI: CE-marked AI fundus analysis software detecting 12 retinal abnormalities including diabetic retinopathy, macular disease, and glaucoma
   • VUNO Med-LungCT AI: AI-based pulmonary nodule detection and reporting system for chest CT
   • VUNO Med-BoneAge: Korea's first AI medical device for pediatric bone age assessment; CE MDR v3.2 certified (January 2026) with explainable AI visualizations

Biosignal AI & Prediction Systems

VUNO Med-DeepCARS: AI cardiac arrest prediction software analyzing EMR vital signs to forecast risk within 24 hours; MFDS-approved, CE MDR/UKCA certified, FDA breakthrough-designated
   • VUNO Med-DeepECG Suite: AI ECG analysis platform including DeepECG AMI (acute myocardial infarction), DeepECG LVSD (heart failure), and DeepECG Hyperkalemia detection

Connected Hardware (HATIV Brand)

HATIV K30: Kiosk-type ECG measurement device for hospital and retail deployment
   • HATIV P30: Home-use portable ECG monitor integrated with DeepECG suite
   • HATIV BP30: Automatic blood pressure monitoring device
   • HATIV TP50T: Ear infrared thermometer

Market Position & Certifications

VUNO holds a pioneering leadership position in    South Korea's medical AI software market as the first domestic company to achieve MFDS approval, CE marking, and FDA clearance for AI diagnostic devices, competing with    Lunit Inc. and global imaging AI developers. Key strengths include:

12 years of Korean AI medical innovation heritage since founding
   • Regulatory firsts: Korea's first approved AI medical device (BoneAge, 2018); first CE-marked Korean AI medtech (2019); first European innovative medical device certification (2020)
   • Clinical validation: DeepCARS demonstrated 46% reduction in in-hospital cardiac arrest (January 2026 confirmation); AUROC 0.860-0.905 across multicenter studies; cited in 2025 AHA CPR guidelines
   • Global partnerships: Samsung Electronics integration; Mayo Clinic Platform collaboration for U.S. market entry; pilot programs with German and Kuwaiti hospitals
   • Financial turnaround: First quarterly operating profit achieved in Q3 2025; 11 consecutive quarters of revenue growth

Corporate Timeline

2014 — Founded in Seoul, South Korea, developing proprietary deep learning framework VunoNet
   2018 — VUNO Med-BoneAge becomes Korea's first MFDS-approved AI medical device
   2019 — First Korean AI medtech company to receive CE marking
   2020 — First European innovative medical device certification for a Korean AI company
   2023 — DeepCARS receives FDA Breakthrough Device Designation
   2024 — VUNO Med-DeepBrain receives FDA 510(k) clearance (October); DeepECG AMI and LVSD receive MFDS approval
   2025 — DeepCARS receives CE MDR and UKCA certifications (May); completes NTAP application for U.S. reimbursement; reports first quarterly operating profit (Q3); revenue reaches KRW 34.8 billion (+35% YoY)
   2026 — DeepCARS study confirms 46% reduction in cardiac arrest (January); BoneAge v3.2 receives CE MDR (January); divests LungCT AI product line to Coreline Soft (early 2026); hosts inaugural Global Patient Safety Summit (February)

Target Markets & Applications

Neurology & Dementia Care: DeepBrain MRI quantification for early Alzheimer's and neurodegenerative disease detection
   • Critical Care & Cardiac Monitoring: DeepCARS for general ward cardiac arrest prediction across 50,000+ hospital beds; DeepECG suite for emergency AMI and heart failure screening
   • Ophthalmology: Fundus AI for diabetic retinopathy and glaucoma screening in primary care and diabetes clinics
   • Pulmonology: Chest X-ray AI for tuberculosis, pneumonia, and lung cancer screening
   • Home & Retail Health: HATIV P30 and K30 for consumer ECG monitoring integrated with AI diagnostics

Contact Information

Global Headquarters

Address: 9F, 479, Gangnam-daero, Seocho-gu, Seoul 06536, South Korea
   Telephone: +82 2 515 6646
   Fax: +82 2 515 6647
   Email: contact@vuno.co

Corporate Status

Entity Type: Publicly Listed Company (No Parent Company)
   Stock: Korea Exchange KOSDAQ: 338220
   Website: vuno.co

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