- No public price. Contact form only.
- Not disclosed
- Not disclosed
- —
- 2013
- KR
Radiology
Lunit
by Lunit · founded 2013 · KR
AI for chest X-ray, mammography and breast tomosynthesis, Volpara breast-density tools, and pathology biomarker software (SCOPE).
On this page
54/100Solid choice
- Regulatory & Compliance18/28
FDA cleared (8 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength26/26
5 peer-reviewed papers
- Vendor & Market14.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (8 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers18/18
5 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
2 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market6/6
Founded 2013 (13 years)
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
AI for chest X-ray, mammography and breast tomosynthesis, Volpara breast-density tools, and pathology biomarker software (SCOPE).
No public price. Contact form only.
Bottom line
Lunit is a Korean radiology AI company with products for chest X-ray, mammography, tomosynthesis and breast density, plus a pathology line aimed at biopharma. It holds six FDA 510(k) clearances, but the chest X-ray one covers triage only, so the brand is broader than its US regulatory scope. Published studies are mixed: good retrospective numbers, weaker prospective ones, and a threshold shift between software versions. Radiology departments and breast screening programs are the buyers. A clinic that wants chest X-ray nodule detection cleared in the US should check the exact product and indication first.
What is Lunit and who sells it?
Lunit Inc. is headquartered in Seoul, was founded in 2013 and has been listed on KOSDAQ (KRX:328130) since July 2022 (Lunit About page, PitchBook). In May 2024 it completed the acquisition of Volpara Health Technologies of Wellington, New Zealand, for about US$193M. Volpara products now run under the Lunit brand (Lunit media hub, Radiology Business). Lunit describes "FDA-cleared and CE-marked (under MDR) products used at 10,000+ sites in 70+ countries" (Lunit website, October 2026).
What does it do?
INSIGHT CXR highlights 11 thoracic abnormalities including nodules, pneumothorax, consolidation, effusion and fractures. It also offers TB screening, normal flagging and comparison with prior images, and can run on premises or in the cloud through a local DICOM gateway that strips identifiers. INSIGHT MMG reads 2D mammograms and INSIGHT DBT reads tomosynthesis. From Volpara come TruDensity, TruPGMI, TruPressure and TruRadDose. The SCOPE suite covers IHC and PD-L1 pathology and is positioned for biomarker development and trials (Lunit product pages).
Lunit cites "up to 95-100%" accuracy from an internal clinical evaluation report. It also says workload fell by 36.2% while sensitivity for urgent cases stayed at 95% (CXR3 study). Both are vendor claims. The CXR page names no PACS or EHR integrations beyond "AI-integrated worklists".
What FDA clearances does Lunit hold?
The FDA 510(k) database lists six records for Lunit, Inc. as of October 2026, all substantially equivalent:
- INSIGHT CXR Triage, K211733, November 2021
- INSIGHT MMG, K211678, November 2021, and a v1.1.10 update, K260320, April 2026
- INSIGHT DBT, K231470, November 2023, with updates K242652 in October 2024 and K253796 in March 2026
Volpara Imaging Software holds two earlier clearances (K182310 in 2018 and K211279 in 2021). The FDA records show triage for chest X-ray, with no nodule-detection or multi-finding clearance. In Europe, INSIGHT CXR and MMG received MDR CE and UKCA marks, announced in November 2022. Lunit's pages do not state the risk class, and third-party registers list CXR as Class IIa. On tuberculosis, Lunit's own timeline says the World Health Organization recommended it as a diagnostic tool to replace medical professionals in TB screening, and gives no date.
What does the evidence say?
A prospective multicenter study in Diagnostics (2023) found a retrospective AUC of 0.94 but a prospective AUC of 0.84 across 4,752 cases, with specificity 0.81 and mostly clinically insignificant false positives. A 2025 PLOS Digital Health comparison of INSIGHT CXR versions for TB reading found that a newer version was less accurate until its threshold was recalibrated (PMID 40233023). Scottish Health Technology Group guidance from 2025 found little evidence on the clinical effectiveness of AI-assisted chest X-ray review, and one study had 62% false positives.
For mammography, a 2026 European Radiology paper (PMID 41927979) looked at AI-detected and undetected breast cancers on INSIGHT MMG v1.1.8.2 and their long-term prognosis. A 2026 Academic Medicine study used INSIGHT CXR in simulations to teach shared decision-making to medical students (PMID 41533654), an education study.
How much does Lunit cost?
Lunit lists no price and offers a contact form as the only route to a quote (Lunit contact page, October 2026).
How does it compare?
Qure.ai, Annalise.ai, Aidoc, ScreenPoint Transpara, Therapixel, Vara, Kheiron and Hologic Genius AI compete in the same radiology categories. Lunit holds clearances for both mammography and tomosynthesis and adds Volpara's density tools. On chest X-ray, Qure.ai holds a cleared lung nodule product where Lunit's clearance is triage.
The verdict
A breast screening program that wants mammography and tomosynthesis AI plus density tools can shortlist Lunit. Ask which modules in the quote are cleared and for which indications, and how version updates are recalibrated. A department buying only for nodule detection on chest films in the US should compare Qure.ai first.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. Contact form only. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) (multiple), CE Mark (EU MDR), UKCA per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
Lunit (Lunit) was founded in 2013 in KR, putting it 13 years into market.
What the literature says
5 peer-reviewed studies indexed on PubMed evaluate Lunit in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Comparison of different Lunit INSIGHT CXR software versions when reading chest radiographs for tuberculosis.
- Codlin AJ, Vo LNQ, Dao TP, et al.· PLOS Digit Health· 2025
- New versions of computer-aided detection (CAD) software for chest X-ray (CXR) interpretation during tuberculosis (TB) screening are regularly released which purport to have incremental performance gains. No studies have independently assessed differences in software performance between the World Health Organization recommended INSIGHT CXR software (Lunit, South Korea). A well-characterized Digital Imaging and Communications in Medicine (DICOM) test library was compiled using data from a community-based TB screening initiative in Ho Chi Minh City, Viet Nam. The performance of Lunit CAD softwar…
- A systematic review and meta-analysis of artificial intelligence software for tuberculosis diagnosis using chest X-ray imaging.
- Han ZL, Zhang YY, Li J, et al.· J Thorac Dis· 2025
- Pulmonary tuberculosis (PTB) remains a global public health challenge, with 10.8 million new cases reported in 2023. Early diagnosis is crucial for controlling its spread, yet traditional sputum-based tests face limitations in turnaround time and resource availability. Chest X-ray (CXR) is a cost-effective diagnostic tool, but its use in high-tuberculosis (TB) burden regions is restricted by a shortage of radiologists. Artificial intelligence (AI)-based computer-aided detection (CAD) systems, leveraging deep learning, offer a promising solution for automated PTB detection. However, variabilit…
- Genomic and transcriptomic analyses of residual invasive triple-negative breast cancer after neoadjuvant chemotherapy in the prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab plus capecitabine compared to capecitabine; KCSG-BR18-21).
- Im SA, Park K, Koh J, et al.· ESMO Open· 2025
- Profiling residual disease after neoadjuvant chemotherapy (NAC) might identify molecular target and tumor microenvironmental features to guide adjuvant therapy. We explored the characteristics of residual triple-negative breast cancer (TNBC) in the prospective MIRINAE trial (KCSG-BR18-21), a phase II study evaluating adjuvant atezolizumab plus capecitabine versus capecitabine in TNBC without pathological complete response after NAC (NCT03756298) through multi-omics analyses. Residual TNBC samples were analyzed for tumor-infiltrating lymphocytes (TILs), programmed death-ligand 1 (PD-L1) immuno…
- Artificial intelligence-assisted shared decision-making training for medical students transitioning to residency.
- Kim YM, Lee YM, Kim DH, et al.· Acad Med· 2026
- Although the use of artificial intelligence (AI) as a diagnostic aid is increasing in clinical practice, medical education provides little training on how to incorporate AI-generated information into diagnosis and use it effectively in shared decision-making (SDM) with patients. The authors developed and piloted a simulation-based course to train AI-assisted SDM to final-year medical students preparing for residency. Conducted between June and October 2023, the course combined online prelearning with onsite simulations using clinically approved AI tools (Lunit INSIGHT CXR, version 3.1.4.1 and…
- Long-term prognostic implications of AI-detected versus AI-undetected breast cancers on mammography: a propensity score-matched analysis.
- Kim HJ, Chae EY, Eom HJ, et al.· Eur Radiol· 2026
- To evaluate the association between the cancer detectability by artificial intelligence (AI) and long-term survival outcomes in invasive breast cancer. This retrospective study analyzed consecutive women diagnosed with invasive breast cancer who underwent preoperative mammography between January and December 2013. Mammograms were analyzed using FDA-cleared AI software (Lunit INSIGHT MMG v1.1.8.2). Cancers were classified as AI-detected if correctly localized by AI, and AI-undetected if AI missed or mislocalized. Propensity score matching was performed using 29 clinical, pathological, and trea…
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