Medical AI Alliance
Company Index
Medical AIKOSDAQ 338220Innovative Medical Device41 approvals

Founded in 2014, VUNO provides AI-based vital-sign and medical imaging diagnostic solutions, including VUNO Med-DeepCARS and VUNO Med-Fundus AI.

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Business overview

Source: DART corporate disclosure

Founded in 2014 and listed on KOSDAQ in 2021, VUNO is a medical AI company. It offers vital-sign products VUNO Med-DeepCARS and HATIV P30, and imaging products VUNO Med-Fundus AI and VUNO Med-Chest X-Ray, alongside technology-licensing agreements. It operates B2H, B2B, and B2C business models with a growing SaaS subscription revenue base, and VUNO Med-DeepCARS received US FDA Breakthrough Device Designation in June 2023 and a USPTO trademark in April 2024.

Products & technology

  • VUNO Med-DeepCARSMonitors 24-hour cardiac arrest risk for inpatients
  • HATIV P30ECG measurement and arrhythmia analysis
  • VUNO Med-Fundus AIDetects 12 abnormal findings in fundus images
  • VUNO Med-Chest X-RayPresents five major findings from chest X-ray images

Regulatory approvals

data.go.kr · openFDA

5 Innovative Medical Device designations · 2020–2025 / 34 Korean MFDS device approvals · 2019–2026 / 2 US FDA 510(k) · 2023–2024

  • InnovativeVN-M-022025-01-20
    Innovative Medical Device designation
  • InnovativeVN-M-042022-12-01
    Innovative Medical Device designation
  • InnovativeVN-C-042021-10-25
    Innovative Medical Device designation
  • InnovativeVN-C-012020-09-22
    Innovative Medical Device designation
  • InnovativeVN-M-032020-07-22
    Innovative Medical Device designation
  • MFDSProduct name not recorded2026-07-22
    Product approval · Class 2인 26-4030 호
  • MFDSProduct name not recorded2026-05-28
    Product approval · Class 2인 26-4020 호
  • MFDSProduct name not recorded2026-03-09
    Product approval · Class 1신 26-28 호
  • MFDSProduct name not recorded2026-02-19
    Product approval · Class 2인 26-4006 호
  • MFDSProduct name not recorded2025-06-23
    Product approval · Class 1신 25-15 호
  • MFDSVital sign, analysis software2025-05-20
    Product approval · Class 2제허 25-329 호
  • MFDSProduct name not recorded2025-05-20
    Product approval · Class 2허 25-329 호
Show 29 more
  • MFDSElectrocardiograph, analysis software2025-05-13
    Product approval · Class 2제허 25-306 호
  • MFDSElectrocardiographic analyser2024-12-10
    Product approval · Class 2제인 24-1126 호
  • FDAVUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage2024-11-15
    510(k) · TraditionalRadiologyK241439
  • MFDSElectrocardiograph, analysis software2024-10-28
    Product approval · Class 2제허 24-739 호
  • MFDSVital sign, analysis software2024-09-04
    Product approval · Class 2제허 24-610 호
  • MFDSElectrocardiograph, analysis software2024-08-07
    Product approval · Class 2제허 24-530 호
  • MFDSElectrocardiograph, analysis software2024-05-02
    Product approval · Class 2제허 24-305 호
  • MFDSOrthopaedic image, computer aided detection/ diagnosis software2023-11-10
    Product approval · Class 2제허 23-1053 호
  • FDAVUNO Med-DeepBrain2023-10-04
    510(k) · TraditionalRadiologyK231398
  • MFDSMedical image, analysis software2023-08-16
    Product approval · Class 2제인 23-5014 호
  • MFDSMedical image, analysis software2023-05-18
    Product approval · Class 2제인 23-4736 호
  • MFDSDental image, computer aided detection/diagnosis software2023-04-18
    Product approval · Class 2제허 23-507 호
  • MFDSU-healthcare gateway software, class 12023-04-12
    Product approval · Class 1제신 23-647 호
  • MFDSProduct name not recorded2023-04-12
    Product approval · Class 1신 23-647 호
  • MFDSElectrocardiographic Holter analyser2022-10-05
    Product approval · Class 2제인 22-4746 호
  • MFDSMedical image, analysis software2022-09-27
    Product approval · Class 2제인 22-4717 호
  • MFDSMedical image, analysis software2022-09-27
    Product approval · Class 2제인 22-4716 호
  • MFDSElectrocardiographic Holter analyser2022-07-29
    Product approval · Class 2제인 22-4574 호
  • MFDSMedical image, analysis software2022-07-08
    Product approval · Class 2제인 22-4515 호
  • MFDSMedical image, analysis software2022-02-24
    Product approval · Class 2제인 22-4150 호
  • MFDSVital sign, analysis software2021-08-23
    Product approval · Class 2제허 21-709 호
  • MFDSOther software, classⅡ, for IVD2021-06-22
    Product approval · Class 2체외 제인 21-4543 호
  • MFDSNeural image, computer aided detection/diagnosis software2020-12-29
    Product approval · Class 3제허 20-1159 호
  • MFDSMedical image, analysis software2020-12-23
    Product approval · Class 2제인 20-5145 호
  • MFDSComputer aided diagnosis software for pathological cells or tissue2020-12-18
    Product approval · Class 3체외 제허 20-1111 호
  • MFDSOphthalmic image, computer aided detection/ diagnosis software2020-04-01
    Product approval · Class 3제허 20-244 호
  • MFDS의료영상진단보조소프트웨어Revoked2019-11-07
    Product approval · Class 3제허 19-705 호
  • MFDSMedical image, computer aided detection/ diagnosis software, class 22019-08-20
    Product approval · Class 2제허 19-551 호
  • MFDSNeural image, analysis software2019-06-24
    Product approval · Class 2제인 19-4502 호

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Companies approved for the same productsMedical AI

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

DEEPNOID Inc.4 shared

Founded in 2008 and listed on KOSDAQ in 2021, DEEPNOID develops medical and industrial AI imaging solutions like DEEP:NEURO.

Coreline Soft Co., Ltd3 shared

Founded in 2012, Coreline Soft provides the AI-based chest CT diagnostic aid suite AVIEW for lung nodules, COPD, and coronary calcification.

JLK, Inc.3 shared

JLK offers the stroke AI solution MEDIHUB STROKE and holds 78 global regulatory approvals, including US FDA and Japan PMDA clearances.

SEERS Co., Ltd.3 shared

Founded in 2009, SEERS provides the wearable ECG analysis solution mobiCARE and the inpatient monitoring solution thynC, based on AI vital-sign analytics.

CU MEDICAL SYSTEMS Inc.2 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

MEDIANA Co.,LTD2 shared

Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.

MEZOO Co., Ltd.2 shared

KOSDAQ-listed medical device company developing the HiCardi wearable patch-type patient monitor.

RAYENCE CO.,LTD.2 shared

KOSDAQ-listed X-ray imaging solution company with a full lineup of medical, dental, veterinary, and industrial X-ray detectors.

INFINITT Healthcare Co., Ltd.1 shared

Founded in 2002, INFINITT Healthcare provides PACS-centered medical imaging software and AI diagnostic aids across multiple clinical specialties.

Lunit Inc.1 shared

Founded in 2013, Lunit provides AI-driven cancer screening and oncology solutions through Lunit INSIGHT and Lunit SCOPE.

NEUROPHET Inc.1 shared

Founded in 2016 and listed on KOSDAQ in 2025, Neurophet develops AI brain-imaging solutions AQUA, SCALE PET, and AQUA AD.

SELVAS Healthcare, Inc.1 shared

SELVAS Healthcare operates the ACCUNIQ medical diagnostic device brand and the HIMS assistive technology device brand.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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