DeepHealth vs Digital Diagnostics
DeepHealth's Saige-Dx reader study in Radiology: AI, 18 readers on 240 cases, put AUC at 0.93 with AI against 0.87 without, but its authors are DeepHealth employees and the set was retrospective and enriched. LumineticsCore from Digital Diagnostics has published papers pointing different ways. A 2025 American Journal of Ophthalmology meta-analysis pooled AUC at 0.95, a 2025 Acta Ophthalmologica comparison gave IDx-DR a kappa of 0.43 against human grading (Mona DR scored 0.68), and a 2026 Scientific Reports real-world study found an exact match with ophthalmologist grading in 54.2% of exams.
A health system buying mammography AI and a community health center buying diabetic eye screening are making separate purchases. Imaging groups with mammography volume go to DeepHealth, whose latest Saige-Dx decision is K253825 in June 2026. Community health centers screening diabetic patients go to LumineticsCore, where Urban Health Plan and OSF HealthCare are named customers. The vendor says it cannot provide pricing and sells only to healthcare providers.
Radiology · Reviewed November 2, 2026
DeepHealth
by RadNet / DeepHealth, Inc.
Imaging AI from RadNet's DeepHealth: mammography (Saige-Dx, Saige-Density), breast arterial calcification, prostate, lung, bone and chest X-ray.

Digital Diagnostics
by Digital Diagnostics Inc.
LumineticsCore: De Novo authorized autonomous AI that detects more than mild diabetic retinopathy from retinal photos.
When to pick each one
DeepHealth
- Saige-Dx mammography detection, decision June 2026
- Ten openFDA records under the DeepHealth name
- Saige-Density breast density assessment
Digital Diagnostics
- Diabetic retinopathy detection in primary care
- Meta-analysis pooled AUC of 0.95
- Billable under CPT 92229
Score
Each row shows points earned of points available under the published rubric.
DeepHealth
48of 100
Digital Diagnostics
28of 100
| Dimension | DeepHealth | Digital Diagnostics | 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 | 7.3 / 18.2 | 0 / 18.2 | +7.3 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 12 / 12 | 3 / 12 | +9 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
DeepHealth
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage shows none. |
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
DeepHealth
FDA decisions
K252486 (opens in new tab)510(k)2026-09-09
ChestView US 1.1 (Gleamer)
K253825 (opens in new tab)510(k)2026-06-15
Saige-Dx
K254131 (opens in new tab)510(k)2026-05-21
Breast arterial calcification (BAC) software
K251873 (opens in new tab)510(k)2025-08-11
Saige-Dx
K243703 (opens in new tab)510(k)2025-06-05
TechLive
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K241620 (opens in new tab)510(k)2025-02-27
ChestView US (Gleamer)
K241593 (opens in new tab)510(k)2025-02-05
BoneMetrics (Gleamer)
K243688 (opens in new tab)510(k)2024-12-19
Saige-Dx 3.1.0
K243705 (opens in new tab)510(k)2024-12-19
Saige-Density 2.5.0
K241747 (opens in new tab)510(k)2024-11-18
Saige-Dx
K240417 (opens in new tab)510(k)2024-11-08
ProFound Detection V4.0 (iCAD)
K222176 (opens in new tab)510(k)2023-03-02
BoneView (Gleamer)
K222275 (opens in new tab)510(k)2022-12-16
Saige-Density
K220105 (opens in new tab)510(k)2022-05-12
Saige-Dx
K212365 (opens in new tab)510(k)2022-03-01
BoneView (Gleamer)
K203517 (opens in new tab)510(k)2021-04-16
Saige-Q (triage)
K203822 (opens in new tab)510(k)2021-03-12
ProFound AI V3.0 (iCAD)
K191994 (opens in new tab)510(k)2019-10-04
ProFound AI V2.1 (iCAD)
Peer-reviewed
1 PubMed record names DeepHealth.
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
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | DeepHealth | Digital Diagnostics |
|---|---|---|
| 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.
