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Medical AIKOSDAQ 328130Innovative Medical Device20 approvals

Lunit Inc.

Official website

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

As of 2026-10-10, Lunit Inc. has 2 MFDS Innovative Medical Device designations, 12 Korean MFDS device approvals, 6 US FDA clearances/approvals, 139 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

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 / 12 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
  • MFDSProduct name not recorded2023-01-17
    Product approval · Class 3허 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
Show 8 more
  • MFDSMedical image, computer aided detection/ diagnosis software, class 22020-10-19
    Product approval · Class 2제허 20-896 호
  • MFDSProduct name not recorded2020-10-19
    Product approval · Class 2허 20-896 호
  • MFDS의료영상검출보조소프트웨어2020-01-13
    Product approval · Class 2제허 20-24 호
  • MFDSProduct name not recorded2020-01-13
    Product approval · Class 2허 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
  • MFDSProduct name not recorded2019-07-29
    Product approval · Class 3허 19-493 호
  • MFDS의료영상검출보조소프트웨어Revoked2018-08-14
    Product approval · Class 2제허 18-574 호

Global clinical trials

ClinicalTrials.gov · sponsor-matched

Key disclosures

KRX KIND via OpenDART
Show 4 more events

Publications

PubMed · affiliation-matched
Show 129 more publications

Patents

KIPRIS · applicant-matched
Show 218 more patents

AI reads

MAA server logs · IP-verified
121
Times AI engines pulled Lunit Inc.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

91
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25
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

16
live 2
Last 7 days
71
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Last 30 days
96
live 5
All time
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  • GoogleGoogleOther6
  • PerplexityPerplexityBot3
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.

INFINITT Healthcare Co., Ltd.85

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

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.

JLK, Inc.80

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

Acryl Inc.75

Founded in 2011, Acryl provides the integrated AI platform Jonathan and the healthcare-specialized AI platform Nadia.

LEMON HEALTHCARE Co.70

Founded in 2017 and listed on KOSDAQ in 2026, Lemon Healthcare operates the LDB medical mydata relay platform for hospitals and insurers.

SELVAS AI Inc.60

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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