Digital Diagnostics vs ScreenPoint Transpara
Breast screening programs and mammography groups buy Transpara. It supports single or double reading on 2D and 3D mammograms, and the vendor says the MASAI trial used it. MASAI was a randomized screening trial of AI-supported against standard double reading, published in the Lancet by Lund University. From it the vendor reports a sensitivity of 80.5% against 73.8% at 98.5% specificity across more than 105,000 women. It also quotes a 29% rise in cancer detection and a 44% cut in workload from separate analyses. openFDA lists eight Transpara clearances, the latest K260898 in August 2026, and the company raised EUR 13.6 million in April 2026, EUR 1.7 million of it grants.
LumineticsCore is indicated for the Topcon NW400 and screens adults with diabetes for diabetic retinopathy. FDA records still carry the product as IDx-DR. For EHR fit it offers "customized workflow integration solutions" and mentions Epic only in a customer testimonial. The vendor names Johns Creek Primary Care and Urban Health Plan as customers, and its FAQ reports Cahaba Medical Care finding diabetic retinopathy in over 1 in 4 patients tested.
One reads mammograms for a screening program and the other reads retinal photographs for a diabetes clinic.
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.

ScreenPoint Transpara
by ScreenPoint Medical
Transpara Breast AI: cancer detection support, density and risk tools for 2D and 3D mammograms.
When to pick each one
Digital Diagnostics
- Indicated for the Topcon NW400 camera
- IDx-DR De Novo of 2018, still the FDA record name
ScreenPoint Transpara
- Detection support on 2D and 3D mammograms
- Eight Transpara 510(k) records, newest August 2026
- Used in the MASAI randomized trial, per vendor
Score
Each row shows points earned of points available under the published rubric.
Digital Diagnostics
28of 100
ScreenPoint Transpara
56of 100
| Dimension | Digital Diagnostics | ScreenPoint Transpara | 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 | 7.8 / 7.8 | -7.8 |
| 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. |
ScreenPoint Transpara
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Virtual demo and contact only. |
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
ScreenPoint Transpara
FDA decisions
K260898 (opens in new tab)510(k)2026-08-14
Transpara (2.1.0)
K241831 (opens in new tab)510(k)2024-11-25
Transpara (2.1.0)
K232096 (opens in new tab)510(k)2023-12-11
Transpara Density 1.0.0
K221347 (opens in new tab)510(k)2022-08-03
Transpara 1.7.2
K210404 (opens in new tab)510(k)2021-06-02
Transpara 1.7.0
Show 3 more
K193229 (opens in new tab)510(k)2020-03-05
Transpara
K192287 (opens in new tab)510(k)2019-12-10
Transpara
K181704 (opens in new tab)510(k)2018-11-21
Transpara
Peer-reviewed
3 PubMed records name ScreenPoint Transpara.
- Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial. (opens in new tab)
- Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
- Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Digital Diagnostics | ScreenPoint Transpara |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | NL |
Scroll horizontally to see both columns.
Common questions
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