Digital Diagnostics vs Hyperfine Swoop
Hyperfine's Swoop is bought as equipment. The FY2025 10-K describes ownership, then an annual software, service and support agreement after a one-year warranty, on 36- or 60-month terms. An older Scientific Reports paper put a system at about $50,000 (currency not stated), and the 10-K sets conventional MRI at about $1.2 million on average. A hospital that wants brain MRI at the bedside, in the ICU or in a resource-limited site is the buyer. Swoop gives T1, T2, FLAIR and DWI but no contrast-enhanced T1.
Hyperfine reported preliminary third-quarter 2026 revenue of about $6.0 million, up 55%, while Yahoo Finance gives a second-quarter 2026 net loss of $9.3 million. A buyer signing a 36- or 60-month service agreement is signing with a loss-making public company.
Digital Diagnostics sells software that grades retinal photos, and a primary care practice that bills CPT 92229 is its buyer. A 2026 Scientific Reports comparison with ophthalmologist fundoscopy found an exact grade match of 54.2% and undergrading in 4.8%. The vendor claims its key trial avoided 91% of unnecessary specialty visits.
Brain MRI and diabetic eye screening are separate purchases.
Radiology · Reviewed November 2, 2026

Digital Diagnostics
by Digital Diagnostics Inc.
LumineticsCore: De Novo authorized autonomous AI that detects more than mild diabetic retinopathy from retinal photos.

Hyperfine Swoop
by Hyperfine
Portable 0.064T brain MRI (Swoop) with Optive AI image reconstruction. Also BrainInsight AI brain morphometry.
When to pick each one
Digital Diagnostics
- Autonomous diabetic retinopathy screening in primary care
- Vendor says 91% of unnecessary specialty visits avoided
Hyperfine Swoop
- Portable 0.064T brain MRI, no shielded room
- Owned system plus annual service agreement
- Hyperfine, Inc. trades on Nasdaq as HYPR
Score
Each row shows points earned of points available under the published rubric.
Digital Diagnostics
28of 100
Hyperfine Swoop
47of 100
| Dimension | Digital Diagnostics | Hyperfine Swoop | 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 | 12.7 / 18.2 | -12.7 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 6 / 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
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
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. |
Evidence
Digital Diagnostics
FDA decisions
K213037 (opens in new tab)510(k)2022-06-17
IDx-DR v2.3
K203629 (opens in new tab)510(k)2021-06-10
IDx-DR
DEN180001 (opens in new tab)De Novo2018-04-11
IDx-DR
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)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Digital Diagnostics | Hyperfine Swoop |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | US |
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.
