Lunit
KOSDAQ-listed Korean AI for breast and chest cancer screening
Overview
Lunit is a KOSDAQ-listed Seoul company selling cancer-screening AI (INSIGHT CXR, MMG and DBT, with MMG and DBT FDA-cleared), breast-screening workflow software from its Lunit International (ex-Volpara) arm, and research-use-only SCOPE pathology biomarker AI. Lunit says more than 8,000 institutions have adopted INSIGHT.
Pricing
Pricing shown for reference only. These figures reflect RECATOOLS research as of 14 Oct 2026 and may be out of date or incomplete. This is not financial or purchasing advice — always confirm the current price on the provider’s official website before making any decision.
What you can produce with Lunit
- INSIGHT CXR chest X-ray AI, with CXR Triage FDA-cleared in 2021
- INSIGHT MMG 2D mammography AI (FDA-cleared)
- INSIGHT DBT 3D tomosynthesis AI (FDA-cleared)
- INSIGHT Risk five-year image-based breast-cancer risk estimate (FDA 510(k) pending)
- Lunit International breast suite: Volpara Scorecard density, Risk Pathways, Analytics and Live
- SCOPE IO, PD-L1, HER2 and uIHC pathology biomarker AI (research use only)
- Deployment through GE Healthcare, Philips, Fujifilm and Hologic distribution
Lunit is one of the few medical-AI vendors with substantial revenue behind it: KRW 45.8 billion in the first half of 2026, up 23%, almost all earned abroad, though it is still loss-making and completed a KRW 211.5 billion rights offering in April. INSIGHT MMG and DBT are FDA-cleared, with updated versions cleared in March and April 2026, and the Volpara acquisition gave it density, risk-workflow and quality software plus a direct US sales force. INSIGHT Risk, its image-based five-year risk model, is still awaiting FDA clearance. SCOPE pathology AI is sold to pharma for research use only.
It is sold by quote through Lunit and imaging partners such as GE Healthcare, Philips, Fujifilm and Hologic, with no public price or self-serve option. For imaging centres that want screening AI with a regulatory record, it belongs on the shortlist; ask for performance data on your own population, since much published evidence is Lunit-authored. It is irrelevant outside radiology and oncology.
What we found
Lunit sells regulated software to hospitals, screening programmes and drug developers, so its record lives in filings and regulatory databases, not star ratings. The KOSDAQ-listed Seoul company reported consolidated revenue of KRW 45.8 billion for the first half of 2026, up 23% year on year, with 95% earned outside Korea. The operating loss for the half was about KRW 29 billion, and management is aiming for EBITDA break-even this year. In April 2026 it completed a KRW 211.5 billion rights offering, mainly to repay debt.
Breast screening is the core business. Lunit INSIGHT MMG and INSIGHT DBT hold FDA clearances, with new versions cleared in March and April 2026, and INSIGHT CXR Triage was cleared in 2021. INSIGHT Risk, which estimates five-year breast-cancer risk from a mammogram and the patient's age, has Breakthrough Device designation and a 510(k) filed in December 2025; Lunit's second-quarter investor letter still called clearance a 2026 target. Buying New Zealand's Volpara in 2024, now Lunit International, added density, quality and risk-workflow software plus direct sales in the US, Canada, Australia and New Zealand. North America supplied about 70% of screening revenue in Q1 2026.
Scale figures need careful reading. The half-year report says more than 8,000 institutions had adopted INSIGHT, while the investor page says 10,000+ sites in 65+ countries. The often-quoted 330 is narrower: providers in the Americas using the combined Lunit and Lunit International breast suite.
Lunit SCOPE, the pathology and biomarker line, is still research-use-only. Its revenue more than doubled to KRW 2.9 billion in the half, mostly pharma collaborations, with partners including AstraZeneca, CellCarta, Leica Biosystems and 10x Genomics.
Evidence quality is the caveat. Lunit cites an external JAMA Oncology comparison of three commercial algorithms in which INSIGHT MMG scored highest, but much of the other performance data comes from Lunit-authored studies. In Southeast Asia, its regulatory page names a Malaysian legal representative and Medical Device Authority registration for Lunit International products.
Compiled by RECATOOLS from public sources: vendor documentation and pricing, code repositories and published reporting.
Frequently asked questions
About this listing
This entry was compiled from publicly available data including Lunit's official website, press releases, documentation, and reputable third-party publications. RECATOOLS is not affiliated with Lunit unless explicitly stated.
Third-party AI tools update their pricing, features, availability, and policies frequently. Information here may be outdated by the time you read this — we make reasonable efforts to keep listings current, but cannot guarantee absolute accuracy.
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