MedAI Verdict
Radiology

AI Radiology

VU

VUNO

by VUNO Inc.  ·  founded 2014  ·  KR

Last verified

FDA-cleared AI for chest X-ray triage and brain MR volumetry, plus Korean-approved bone age and retinal screening tools.

Visit VUNO (opens in new tab)Read our methodology

At a glance

Pricing
No public price.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
2014
HQ
KR
On this page

Independent score  ·  By our public rubric

73/100Top-ranked

Editorial rating 5.0 / 5

How it’s computed →
  • Regulatory & Compliance
    18/28

    FDA cleared (2 K-numbers on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    26/26

    5 peer-reviewed papers

  • Vendor & Market
    14.4/18

    Mid-tier funding and adoption

  • Sentiment & Transparency
    2.5/5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (2 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • EHR integrations (count)0/4

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/2

    None of the top-3 EHRs covered

Evidence Strength

  • Peer-reviewed papers18/18

    5 peer-reviewed papers

  • RCT / meta-analysis / systematic review8/8

    1 RCT/Meta-Analysis/Systematic Review

Vendor & Market

  • Funding & adoption signal8/12

    Mid-tier funding and adoption

  • Years in market6/6

    Founded 2014 (12 years)

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

FDA-cleared AI for chest X-ray triage and brain MR volumetry, plus Korean-approved bone age and retinal screening tools.

No public price.

Evidence record

FDA decisions
Peer-reviewed

5 studies on PubMed: 3 other, 1 observational, 1 RCT, published 2024 to 2026. Read the literature summary

Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, VUNO record, https://medaiverdict.com/tools/vuno, version November 2, 2026

Change history
View every change to this record

Bottom line

VUNO is a Seoul company with six product lines: chest X-ray, brain MR, retinal fundus, bone age, cardiac arrest risk from vital signs and a personal-health platform. FDA cleared two of them, DeepBrain brain MR volumetry in October 2023 and a chest X-ray triage tool for pleural effusion and pneumothorax in November 2024, and US availability of the triage tool is not stated. Hospitals that want brain MR volumetry fit. Bone age and retinal screening carry Korean MFDS approvals, and the company history records CE marking of five VUNO Med solutions in June 2020.

What did FDA clear?

K231398 (VUNO Med-DeepBrain, October 4, 2023) covers automatic labeling, visualization and volumetric quantification of brain structures and lesions from MR, for trained healthcare professionals. The vendor's page describes 3D T1 input, white matter hyperintensity from 2D T2 FLAIR, and comparison against normative percentiles. K241439 (VUNO Med-Chest X-ray Triage and Med-CXR Link Triage, November 15, 2024) is computer-assisted triage and notification for adult chest X-rays with pleural effusion and/or pneumothorax.

The chest page describes screening support for five major findings across lung cancer, tuberculosis and pneumonia. The FDA record for the chest tool covers pleural effusion and pneumothorax triage.

What else does the company hold?

MFDS approved Med-BoneAge in May 2018, which the company history calls Korea's first AI medical device, and Med-Fundus AI as Class III in April 2020. DeepCARS, which estimates cardiac arrest risk within 24 hours from vital signs in general-ward patients, holds an FDA Breakthrough designation from June 2023. A Breakthrough designation is not a clearance.

What do the studies show?

For DeepBrain, a 2022 PLoS One study (PMID 36107961) reported 96.4% sensitivity and 89.9% specificity for moderate to severe white matter hyperintensity volume, graded by Fazekas classification. No peer-reviewed accuracy paper for the chest tool was found in PubMed. The chest page gives no accuracy numbers and cites an RSNA 2019 abstract and an MFDS clinical trial at Asan Hospital.

Bone age, which has no FDA decision, has the most papers, including a comparison with BoneXpert in Turkish children (PMID 39221654). Several studies are Korean single-country work, and independence from VUNO is not verified.

What is the company?

VUNO Inc. was founded in December 2014 and listed on KOSDAQ in February 2021. Its privacy policy lists ISO/IEC 27001:2022. The US entity is VUNO MED INC.

Pricing

No public price.

The verdict

VUNO fits a hospital that wants brain MR lesion volumetry or effusion and pneumothorax triage from a Korean vendor. A bone age or retinal screening program works from Korean MFDS approvals, with no FDA decision for either product. The Breakthrough designation held by DeepCARS is the only other FDA status in the company history.

Editorial review last generated November 2, 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.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k), CE, ISO/IEC 27001:2022, ISO/IEC 27701:2019 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

Who builds it

VUNO (VUNO Inc.) was founded in 2014 in KR, putting it 12 years into market.

What the literature says

5 peer-reviewed studies indexed on PubMed evaluate VUNO in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.

A comparison of two artificial intelligence-based methods for assessing bone age in Turkish children: BoneXpert and VUNO Med-Bone Age. (opens in new tab)
Özmen E, Özen Atalay H, Uzer E, et al.· Diagn Interv Radiol· 2025Observational
This study aimed to evaluate the validity of two artificial intelligence (AI)-based bone age assessment programs, BoneXpert and VUNO Med-Bone Age (VUNO), compared with manual assessments using the Greulich-Pyle method in Turkish children. This study included a cohort of 292 pediatric cases, ranging in age from 1 to 15 years with an equal gender and number distribution in each age group. Two radiologists, who were unaware of the bone age determined by AI, independently evaluated the bone age. The statistical study involved using the intraclass correlation coefficient (ICC) to measure the level…
Clinical Effectiveness of AI-Based Cardiac Arrest Prediction System for General Ward Patients (VITAL-MD): Protocol for a Multicenter Pragmatic Stepped Wedge Cluster Randomized Controlled Trial. (opens in new tab)
Kim M, Kim KH, Kim M, et al.· JMIR Res Protoc· 2026RCT
In-hospital cardiac arrest (IHCA) remains a frequent and devastating event, and conventional early warning scores (EWSs) coupled with rapid response systems (RRSs) have shown inconsistent effects on patient-centered outcomes, largely owing to limited predictive accuracy and high false-alarm burden. AI-based EWSs (AI-EWSs) have demonstrated superior discrimination retrospectively, but high-quality prospective evidence in true external validation environments remains scarce. Existing AI-EWS trials have either been confined to internal-development settings or bundled the algorithm with specific…
Combined diagnostic accuracy of two artificial intelligence systems for glaucoma diagnosis using color fundus photography. (opens in new tab)
da Silva Filho GV, Caiado GC, Yamamoto FZ, et al.· PLoS One· 2026
To evaluate the diagnostic accuracy of two commercially available artificial intelligence (AI) systems based on color fundus photography (CFP), the Laguna ONhE and VUNO Med-Fundus AI, for glaucoma detection, both independently and in combination. This retrospective cross-sectional study included 370 eyes from 193 patients (248 eyes with primary open-angle glaucoma and 122 healthy eyes). All eyes underwent structural evaluation with swept-source optical coherence tomography (Triton, Topcon) and visual field testing (Octopus 900, Haag-Streit AG). Fundus photographs were analyzed using Laguna ON…
Comparison of Two Artificial Intelligence Programs for Bone Age Assessment Using Hand-Wrist Radiographs in Korean Children and Adolescents Undergoing Orthodontic Diagnosis. (opens in new tab)
Park EJ, Shin HW, An SY· Children (Basel)· 2026
Accurate assessment of skeletal maturation is important for timing pediatric dental and orthodontic interventions. This study compared bone age estimates generated by two AI-based programs, CRESCOM MediAI-BA and VUNO Med-BoneAge, in Korean children and adolescents undergoing orthodontic diagnostic evaluation.This retrospective study compared bone-age estimates generated by CRESCOM MediAI-BA and VUNO Med-BoneAgeusing left hand-wrist radiographs from 200 Korean children and adolescents (100 boys and 100 girls; 6-17 years) undergoing orthodontic diagnostic evaluation. Chronological age and progr…
Impact of white matter hyperintensity volumes estimated by automated methods using deep learning on stroke outcomes in small vessel occlusion stroke. (opens in new tab)
Lee M, Suh CH, Sohn JH, et al.· Front Aging Neurosci· 2024
Although white matter hyperintensity (WMH) shares similar vascular risk and pathology with small vessel occlusion (SVO) stroke, there were few studies to evaluate the impact of the burden of WMH volume on early and delayed stroke outcomes in SVO stroke. Using a multicenter registry database, we enrolled SVO stroke patients between August 2013 and November 2022. The WMH volume was estimated by automated methods using deep learning (VUNO Med-DeepBrain, Seoul, South Korea), which was a commercially available segmentation model. After propensity score matching (PSM), we evaluated the impact of WM…

See all on PubMed (opens in new tab)

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