Clarius vs Milvue
Milvue Suite is CE marked as class IIa under MDR 2017/745 with BSI as notified body. openFDA gives SmartChest as K232410 (May 2024) and TechCare Trauma as K242171 (January 2025, product code QBS, fracture detection). The vendor says it marks fractures and measures bones on conventional radiographs and moves flagged exams up the worklist. It lists DICOM and HL7 exchange and RIS and PACS partners such as Dedalus, Intrasense and Osimis, and names Groupe Vidi and GMM Group as imaging-group partners.
The AI sits inside the Clarius scanner. Its AI page marks features as CE Marked across Europe and the UK and labels several as available in select markets.
These are a hardware purchase and a software purchase. A clinician who scans at the bedside buys Clarius, and an imaging group that wants fracture and chest findings in its worklist buys Milvue.
Radiology · Reviewed November 2, 2026
Clarius
by Clarius Mobile Health
Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.
Milvue
by Milvue
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.
When to pick each one
Clarius
- Scanner with AI built in, per vendor
- AI features marked CE for Europe and the UK, per vendor
Milvue
- CE class IIa under MDR, notified body BSI
- TechCare Trauma and SmartChest hold FDA 510(k) clearance
- Vendor lists DICOM and HL7 exchange with RIS and PACS partners
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
Milvue
55of 100
| Dimension | Clarius | Milvue | 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 | 12.7 / 18.2 | 18.2 / 18.2 | -5.5 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 3.9 / 7.8 | +3.9 |
| Funding & adoption signal | 3 / 12 | 3 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Milvue
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Clarius
FDA decisions
K253593 (opens in new tab)510(k)2026-03-02
Clarius Ejection Fraction AI
K250226 (opens in new tab)510(k)2025-05-08
Clarius Median Nerve AI
K243853 (opens in new tab)510(k)2025-04-16
Clarius Prostate AI
K233955 (opens in new tab)510(k)2024-06-14
Clarius OB AI
K232257 (opens in new tab)510(k)2023-11-13
Clarius Bladder AI
Show 1 more
K222406 (opens in new tab)510(k)2023-01-23
Clarius AI
Peer-reviewed
3 PubMed records name Clarius.
- Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
- Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
- Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology Study- Focus on Synovitis, Doppler Activity, Erosions, and Tendon Lesions. (opens in new tab)
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)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | Milvue |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | FR |
Scroll horizontally to see both columns.
Common questions
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Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.