Hyperfine Swoop vs Milvue
Milvue reads conventional radiographs, flags fractures, dislocations and joint effusions, and moves flagged exams up the worklist. In the US it holds SmartChest (K232410, decided May 10, 2024) and TechCare Trauma (K242171, January 17, 2025). The vendor reports fracture AUC 0.962 from the FDA study, and in the FDA reader study adult fracture sensitivity up 22% with reading time down 24%. Its partners page names Dedalus, Intrasense and Osimis among RIS and PACS partners, with DICOM and HL7 interfaces. Hyperfine's homepage describes the Swoop as an AI-powered, portable brain MRI built on a magnet with a fraction of conventional field strength. It produces T1, T2, T2-FLAIR and DWI images, and a Malawi implementation paper lists lower signal-to-noise, longer scans and no contrast-enhanced T1. Optive AI reconstruction reached the installed base in July 2025, with CE and UKCA marks in August 2025. Hyperfine's homepage names no PACS or cloud vendor. An emergency radiology service reading trauma films fits Milvue, and an ICU needing brain imaging at the bedside fits Hyperfine.
Radiology · Reviewed November 2, 2026

Hyperfine Swoop
by Hyperfine
Portable 0.064T brain MRI (Swoop) with Optive AI image reconstruction. Also BrainInsight AI brain morphometry.

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
Hyperfine Swoop
- Bedside 0.064T brain MRI with Optive AI reconstruction
- Structural contrasts T1, T2, FLAIR and DWI
Milvue
- Fracture detection on radiographs, TechCare Trauma K242171
- Native RIS/PACS integration, DICOM and HL7
Score
Each row shows points earned of points available under the published rubric.
Hyperfine Swoop
47of 100
Milvue
55of 100
| Dimension | Hyperfine Swoop | 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 | 0 / 7.8 | 3.9 / 7.8 | -3.9 |
| Funding & adoption signal | 6 / 12 | 3 / 12 | +3 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Hyperfine Swoop
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Per the FY2025 10-K summary, systems are owned, with an annual software, service and support agreement after a one-year warranty on 36- or 60-month terms. Dollar amounts were not found. |
Milvue
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Hyperfine Swoop
FDA decisions
K262622 (opens in new tab)510(k)2026-08-19
Swoop
K253489 (opens in new tab)510(k)2025-12-12
Swoop
K250236 (opens in new tab)510(k)2025-05-30
Swoop (V2)
K251276 (opens in new tab)510(k)2025-05-21
Swoop
K240944 (opens in new tab)510(k)2024-07-16
Swoop
Show 12 more
K232760 (opens in new tab)510(k)2023-10-06
Swoop
K230208 (opens in new tab)510(k)2023-02-22
Swoop
K223268 (opens in new tab)510(k)2022-12-16
BrainInsight
K223247 (opens in new tab)510(k)2022-12-06
Swoop
K221923 (opens in new tab)510(k)2022-07-28
Swoop
K220815 (opens in new tab)510(k)2022-07-19
BrainInsight
K221393 (opens in new tab)510(k)2022-06-10
Swoop
K212456 (opens in new tab)510(k)2021-11-17
Swoop
K211818 (opens in new tab)510(k)2021-07-07
Swoop
K202414 (opens in new tab)510(k)2021-01-07
BrainInsight
K201722 (opens in new tab)510(k)2020-08-11
Hyperfine POC MRI
K192002 (opens in new tab)510(k)2020-02-06
Lucy POC MRI
Peer-reviewed
4 PubMed records name Hyperfine Swoop.
- Super resolution using sparse sampling at portable ultra-low field MR. (opens in new tab)
- Tips and challenges for clinical use and interpretation of low field portable MRI in neuroimaging. (opens in new tab)
- Case-based review of low-field MRI in resource-constrained settings: a clinical perspective from Malawi. (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 | Hyperfine Swoop | Milvue |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | 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.
