Medical AI Alliance
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Medical AIKOSDAQ 328130Innovative Medical Device16 approvals

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

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Business overview

Source: DART corporate disclosure

Founded in 2013 and listed on KOSDAQ in 2022, Lunit is a deep learning-based medical AI company. It provides the AI-assisted detection solution Lunit INSIGHT and the imaging biomarker solution Lunit SCOPE, distributed globally through partnerships with GE Healthcare, Philips, Fujifilm, and Hologic. Consolidated revenue reached KRW 83,129 million at the end of 2025 (8% domestic, 92% overseas), with over 3,600 institutions and 9,500 clinicians worldwide using its solutions to analyze roughly 19.7 million medical images annually.

Products & technology

  • Lunit INSIGHTAI-assisted detection for cancer screening, including breast cancer
  • Lunit SCOPEImaging biomarker for histopathology analysis and treatment response prediction

Regulatory approvals

data.go.kr · openFDA

2 Innovative Medical Device designations · 2020–2021 / 8 Korean MFDS device approvals · 2018–2023 / 6 US FDA 510(k) · 2021–2026

  • InnovativeLunit INSIGHT MMG 외 2건2021-09-02
    Innovative Medical Device designation
  • InnovativeLunit INSIGHT CXR2020-09-18
    Innovative Medical Device designation
  • FDALunit INSIGHT MMG (v1.1.10)2026-04-23
    510(k) · SpecialRadiologyK260320
  • FDALunit INSIGHT DBT (V1.2)2026-03-26
    510(k) · TraditionalRadiologyK253796
  • FDALunit INSIGHT DBT v1.12024-10-04
    510(k) · SpecialRadiologyK242652
  • FDALunit INSIGHT DBT2023-11-06
    510(k) · TraditionalRadiologyK231470
  • MFDSBreast cancer image, computer aided detection/ diagnosis software2023-01-17
    Product approval · Class 3제허 23-36 호
  • MFDSComputer aided diagnosis software for pathological cells or tissueRevoked2022-06-20
    Product approval · Class 3체외 제허 22-395 호
  • MFDSMedical image, computer aided detection/ diagnosis software, class 22022-02-16
    Product approval · Class 2제인 22-4113 호
  • FDALunit INSIGHT MMG2021-11-17
    510(k) · TraditionalRadiologyK211678
  • FDALunit INSIGHT CXR Triage2021-11-10
    510(k) · TraditionalRadiologyK211733
  • MFDSMedical image, computer aided detection/ diagnosis software, class 22020-10-19
    Product approval · Class 2제허 20-896 호
Show 4 more
  • MFDS의료영상검출보조소프트웨어2020-01-13
    Product approval · Class 2제허 20-24 호
  • MFDS의료영상검출보조소프트웨어Revoked2019-10-21
    Product approval · Class 2제허 19-660 호
  • MFDSBreast cancer image, computer aided detection/ diagnosis software2019-07-29
    Product approval · Class 3제허 19-493 호
  • MFDS의료영상검출보조소프트웨어Revoked2018-08-14
    Product approval · Class 2제허 18-574 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.2 shared

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

Coreline Soft Co., Ltd1 shared

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

Noul Co., Ltd.1 shared

Founded in 2015 and listed on KOSDAQ in 2022, Noul develops the on-device AI diagnostic platform miLab™ for blood and cancer testing.

RAYENCE CO.,LTD.1 shared

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

VUNO, Inc.1 shared

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

SEERS Co., Ltd.100

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

SyntekaBio,Inc.85

Founded in 2009, SyntekaBio provides genomic big data-based AI drug discovery platforms DeepMatcher and NEO-ARS, along with the NGS-ARS precision medicine service.

Oncocross Co.,Ltd.85

Founded in 2015, Oncocross provides the disease-drug matching AI platform RAPTOR AI and the oncology-specialized ONCO-RAPTOR AI.

JLK, Inc.80

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

LEMON HEALTHCARE Co.70
SELVAS AI Inc.60

SELVAS AI provides voice and language AI technologies through its HCI and AI Digital Transformation business units.

INFINITT Healthcare Co., Ltd.60

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

Sources and updates

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

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