Iterative Health vs Milvue
SKOUT flags colorectal polyps on the live video feed during colonoscopy, and Milvue reads finished radiographs, so they serve different departments. openFDA lists six SKOUT decisions under product code QNP, from K213686 on August 12, 2022 to K253664 on December 22, 2025. Iterative Health's home page now leads with clinical research for providers and sponsors, and its About page names GI Alliance and One GI as partners.
An endoscopy center weighing SKOUT has a sponsor-run 2022 Gastroenterology trial to read: 1.05 adenomas per colonoscopy with the tool against 0.83 without (P=.002), while the adenoma detection rate rose from 43.9% to 47.8% without reaching significance (P=.065).
Milvue's TechCare Trauma (K242171, January 17, 2025) detects fractures, SmartChest (K232410, May 10, 2024) covers chest films, and flagged exams move up the worklist. Its partners page lists imaging groups including Groupe Vidi, and RIS and PACS vendors such as Dedalus and Osimis.
Radiology · Reviewed November 2, 2026
Iterative Health
by Iterative Health · founded 2017
Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.
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
Iterative Health
- Real-time polyp detection during colonoscopy
- Six SKOUT clearances, product code QNP
Milvue
- Fracture detection on radiographs, TechCare Trauma K242171
- CE class IIa under MDR, notified body BSI
- RIS and PACS partners including Dedalus and Osimis
Score
Each row shows points earned of points available under the published rubric.
Iterative Health
42of 100
Milvue
55of 100
| Dimension | Iterative Health | 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 | 8.4 / 12 | 3 / 12 | +5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 0 / 6 | +6 |
Scroll horizontally to see every column.
Pricing
Iterative Health
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
Milvue
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Iterative Health
FDA decisions
K253664 (opens in new tab)510(k)2025-12-22
SKOUT system
K251126 (opens in new tab)510(k)2025-05-09
SKOUT system
K241508 (opens in new tab)510(k)2024-07-03
SKOUT system
K240781 (opens in new tab)510(k)2024-04-19
SKOUT system
K230658 (opens in new tab)510(k)2023-04-07
SKOUT system
Show 1 more
K213686 (opens in new tab)510(k)2022-08-12
SKOUT Software
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 | Iterative Health | Milvue |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2017 | n/a |
| HQ | US | FR |
Scroll horizontally to see both columns.
Common questions
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