Milvue vs Qure.ai
Milvue's CE mark is class IIa under MDR 2017/745 with notified body BSI. Its US clearances are SmartChest (K232410, May 2024) and TechCare Trauma (K242171, January 2025), the latter fracture computer-aided detection on radiographs. Qure.ai's records name qER, qXR and qCT products, with qER head CT triage first in June 2020.
An emergency department working a radiograph worklist looks at Milvue, which lists Dedalus, Intrasense and Osimis among its RIS and PACS partners. A hospital that wants head CT hemorrhage triage or lung nodule CT looks at Qure.ai, since Milvue's pages describe conventional radiography and list thorax nodule detection for Europe only.
Milvue cites a 2023 Bousson study of 1,210 emergency patients, 90.1% accuracy against 88.8% and 71.0% for two other commercial tools. Qure.ai's RADICAL study in NHS Greater Glasgow and Clyde is documented in BMJ Open as a stepped-wedge protocol.
On chest radiographs the two overlap, since SmartChest and Qure.ai's qXR-PTX-PE (K230899) both carry product code QFM, so the rest of the worklist decides: fractures point to Milvue and head CT to Qure.ai.
Radiology · Reviewed November 2, 2026
When to pick each one
Milvue
- Fracture detection on radiographs, K242171 January 2025
- RIS and PACS partners include Dedalus and Osimis
Qure.ai
- Head CT triage, lung nodule CT, chest X-ray
- CE Class IIb under MDR for qXR v4.0
Score
Each row shows points earned of points available under the published rubric.
Milvue
55of 100
Qure.ai
50of 100
| Dimension | Milvue | Qure.ai | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 18.2 / 18.2 | 12.7 / 18.2 | +5.5 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 0 / 7.8 | +3.9 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Milvue
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Qure.ai
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Grant funding is not stated on Qure pages. |
Evidence
Milvue
FDA decisions
K242171 (opens in new tab)510(k)2025-01-17
TechCare Trauma
K232410 (opens in new tab)510(k)2024-05-10
SmartChest
Peer-reviewed
5 PubMed records name Milvue.
- Can artificial intelligence pass the Fellowship of the Royal College of Radiologists examination? Multi-reader diagnostic accuracy study. (opens in new tab)
- Small lesion-high risk: diagnostic performance of artificial intelligence in paediatric fractures with medicolegal impact. (opens in new tab)
- Artificial intelligence for pediatric fracture detection: impact on diagnostic revisions and patient recall rates in a tertiary emergency setting. (opens in new tab)
Qure.ai
FDA decisions
K261517 (opens in new tab)510(k)2026-09-14
qCT Lung v1.0
K251934 (opens in new tab)510(k)2026-01-16
qXR-Detect
K251610 (opens in new tab)510(k)2025-09-08
qER-CTA v1.0
K240740 (opens in new tab)510(k)2024-08-16
qCT LN Quant
K231805 (opens in new tab)510(k)2023-12-22
qXR-LN
Show 5 more
K231149 (opens in new tab)510(k)2023-09-22
qXR-CTR
K230899 (opens in new tab)510(k)2023-08-22
qXR-PTX-PE
K212690 (opens in new tab)510(k)2021-12-21
qXR-BT
K211222 (opens in new tab)510(k)2021-07-30
qER-Quant
K200921 (opens in new tab)510(k)2020-06-17
qER
Peer-reviewed
4 PubMed records name Qure.ai.
- Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation. (opens in new tab)
- Revolutionizing Healthcare: Qure.AI's Innovations in Medical Diagnosis and Treatment. (opens in new tab)
- A Case Series From a Multicentric Study: Can Artificial Intelligence (AI)-Enabled Chest X-Ray Assist in the Incidental Detection of Early-Stage Lung Cancers? (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Milvue | Qure.ai |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | FR | IN |
Scroll horizontally to see both columns.
Common questions
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