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Milvue

by Milvue  ·  FR

Last verified

AI fracture and chest X-ray detection with FDA 510(k) clearance in the US, plus a report pre-fill tool the vendor calls not a device.

Visit Milvue (opens in new tab)Read our methodology

At a glance

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

Independent score  ·  By our public rubric

55/100Solid choice

Editorial rating 4.0 / 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
    22.1/26

    5 peer-reviewed papers

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • 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 review4/8

    1 observational study (no RCT)

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

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

AI fracture and chest X-ray detection with FDA 510(k) clearance in the US, plus a report pre-fill tool the vendor calls not a device.

No public price.

Bottom line

Milvue, a Paris company, sells AI detection and measurement on conventional radiographs under two sets of names. Milvue says its Milvue Suite is CE marked at class IIa under MDR, and in the US it markets TechCare Trauma and SmartChest. FDA's records list two clearances, SmartChest (K232410) in May 2024 and TechCare Trauma (K242171) in January 2025. Emergency departments and imaging groups reading fracture and chest films are the buyers. The vendor does not describe the European thorax findings, such as nodules and opacities, or the 50+ bone measurements as FDA cleared.

What does Milvue say it does?

Milvue says its detection covers fractures, dislocations and joint effusions on adult and pediatric radiographs, with pneumothorax, opacities, nodules and pleural effusions in Europe only. It says flagged exams move up the worklist and that the CE version covers all ages from birth, excluding critical care units. Milvue says measurement runs to more than 50 automatic bone measurements across the lower limbs, EOS full body images, bone age, Cobb angle and the weight bearing foot.

Milvue says a report module prefills a narrative report in the radiologist's template in up to 20 languages, and the vendor states that TechCare Report is not a medical device. Outside the US the vendor markets TechCare Alert, Metrics and Report.

Regulation, integration and buying

Milvue says its CE mark is number 2797 at class IIa with BSI as notified body, and that SmartTrauma holds a Health Canada class II license. It cites NICE guidance HTG739 from January 2025, which it says lists TechCare Alert among four AI technologies for NHS fracture detection.

On integration the vendor describes native RIS and PACS connections with DICOM in and out, IHE profiles and HL7, naming Dedalus and Osimis among its RIS and PACS partners. Milvue shows no public price.

Which studies does Milvue cite?

The performance figures are the vendor's citations. Milvue reports a fracture AUC of 0.962 for TechCare Trauma in the FDA study behind K242171. It cites Bousson and colleagues (Academic Radiology 2023, 1,210 emergency patients) for 90.1% accuracy against 88.8% and 71.0% for two other commercial tools. Its reader study gains, nodule AUC and measurement productivity figures are likewise vendor-cited.

The verdict

Milvue targets hospital imaging groups in Europe or the US that read trauma radiographs and want fracture flags and bone measurements inside the existing RIS and PACS. The thorax findings listed as Europe only are not described as FDA cleared. The Bousson comparison, the one head to head figure cited, sets Milvue against two unnamed commercial tools.

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 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

What the literature says

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

Can artificial intelligence pass the Fellowship of the Royal College of Radiologists examination? Multi-reader diagnostic accuracy study. (opens in new tab)
Shelmerdine SC, Martin H, Shirodkar K, et al.· BMJ· 2022
To determine whether an artificial intelligence candidate could pass the rapid (radiographic) reporting component of the Fellowship of the Royal College of Radiologists (FRCR) examination. Prospective multi-reader diagnostic accuracy study. United Kingdom. One artificial intelligence candidate (Smarturgences, Milvue) and 26 radiologists who had passed the FRCR examination in the preceding 12 months. Accuracy and pass rate of the artificial intelligence compared with radiologists across 10 mock FRCR rapid reporting examinations (each examination containing 30 radiographs, requiring 90% accurac…
Small lesion-high risk: diagnostic performance of artificial intelligence in paediatric fractures with medicolegal impact. (opens in new tab)
Pape J, Deffaa OJ, Zimmermann P, et al.· Pediatr Radiol· 2026Observational
Certain paediatric fractures carry a high medicolegal risk if overlooked. While artificial intelligence (AI)-based diagnostic tools have demonstrated promising results in general fracture detection, their accuracy in identifying rare but high-risk paediatric injuries remains insufficiently studied. To assess the diagnostic performance of a commercial AI-based software (SmartUrgence, Milvue, Paris, France) in detecting a predefined set of medicolegally relevant paediatric fractures. This retrospective, single-centre study analysed radiographs from 125 paediatric patients (ages 2 years to &#x22…
Artificial intelligence for pediatric fracture detection: impact on diagnostic revisions and patient recall rates in a tertiary emergency setting. (opens in new tab)
Deffaa OJ, Pape J, Schlösser D, et al.· BMC Emerg Med· 2026
Artificial intelligence (AI) can support and enhance radiologists in musculoskeletal imaging, but evidence of clinical benefit is still lacking. This prospective study aimed to estimate the range of expected effect size on patient recall rates whether after implementation of an AI system for fracture detection affects in a paediatric emergency setting during out-of-hourse care. Children and adolescents (2-18 years) undergoing appendicular skeletal radiography between April and September 2025 during on-call hours at a tertiary referral hospital were eligible. On every second day, automated fra…
Evaluating artificial intelligence in the diagnosis of hip fractures: an analysis of sensitivity, specificity, positive and negative predictive values, and accuracy. (opens in new tab)
Christensen MH, Elsoe R, Mahdi F, et al.· Skeletal Radiol· 2026
To evaluate the diagnostic performance of Milvue SmartUrgences AI software for detecting hip fractures on radiographs obtained in the emergency department (ED). This retrospective diagnostic accuracy study included consecutive patients aged ≥ 60 years undergoing hip and pelvis radiography at two EDs between June 2023 and September 2024. The index test was Milvue SmartUrgences, which classified radiographs as "YES," "NO," or "DOUBT." The reference standard was established by a consensus panel of three musculoskeletal radiologists and two senior orthopaedic trauma surgeons,…
AI vs FRCR: What it means for the future. (opens in new tab)
Ranjan A, Parpaleix A, Cardoso J, et al.· Eur J Radiol· 2023
A recent work by Shelmerdine et al. was published in the Christmas edition of the BMJ. The authors were inspired by George Hinton's statement that artificial intelligence (AI) would supersede radiologists, and ventured to investigate whether the AI software Milvue Suite which had been trained on a few hundred thousand chest and musculoskeletal x-rays, could pass the rapid reporting section of the FRCR - an exam which must be passed in order to practice as a consultant radiologist in the UK. This brief comment sums up the company's opinions and perspective from the practical AI developmental a…

See all on PubMed (opens in new tab)

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