Exo vs Milvue
Milvue is a radiology-department product. It reads conventional radiographs and, the vendor says, moves flagged exams up the worklist. The vendor lists DICOM and HL7 integration and a set of RIS and PACS partners. Milvue states CE class IIa under MDR, and openFDA shows two decisions, K232410 SmartChest on May 10, 2024 and K242171 TechCare Trauma on January 17, 2025. Its partner list includes the imaging groups Groupe Vidi and GMM Group.
Exo Iris is for the clinician who scans the patient directly. It is handheld ultrasound with Lung AI, cardiac measurements and fluid tools, and openFDA lists Lung AI (K243239) on April 24, 2025.
For a US emergency department that wants AI on pleural effusion, Milvue loses. Its detection page lists pleural effusions among findings offered in Europe only, while Exo's June 2025 release calls its lung AI the first FDA-cleared point-of-care ultrasound AI for pleural effusion and consolidation.
Radiology · Reviewed November 2, 2026
When to pick each one
Exo
- Handheld ultrasound for bedside clinicians
- Lung AI K243239 listed on openFDA April 24, 2025
- Vendor calls its effusion AI the first FDA-cleared in POCUS
Milvue
- Fracture and chest radiograph AI that reorders the worklist
- Vendor lists DICOM and HL7 plus named RIS and PACS partners
- Vendor states CE class IIa under MDR
Score
Each row shows points earned of points available under the published rubric.
Exo
28of 100
Milvue
55of 100
| Dimension | Exo | 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 | 0 / 18.2 | 18.2 / 18.2 | -18.2 |
| RCT / meta-analysis / systematic review | 0 / 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
Exo
| 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
Exo
FDA decisions
K260217 (opens in new tab)510(k)2026-02-24
AI Platform 2.2 (AIP002)
K243239 (opens in new tab)510(k)2025-04-24
Lung AI (LAI001)
K242359 (opens in new tab)510(k)2024-11-20
Strain AI (SAI001)
K240953 (opens in new tab)510(k)2024-08-05
AI Platform 2.0 (AIP002)
K232501 (opens in new tab)510(k)2023-11-17
AI Platform (AIP001)
Show 3 more
K230497 (opens in new tab)510(k)2023-06-22
Bladder AI (AIBV01)
K222198 (opens in new tab)510(k)2022-11-09
Exo Iris (EI2001)
K211527 (opens in new tab)510(k)2021-08-20
Exo Iris
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 | Exo | Milvue |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | FR |
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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.