Digital Diagnostics vs Iterative Health
SKOUT is aimed at endoscopists and endoscopy centers. It has six clearances, all under product code QNP, from K213686 in August 2022 to K253664 in December 2025. GI Alliance, One GI and US Heart & Vascular are partners of the company, whose home page now leads with clinical research. SKOUT's page offers a demo request only, with no public price, and it names no endoscopy processor.
LumineticsCore started as a De Novo decision in April 2018 (DEN180001, IDx-DR), then two 510(k)s followed, K203629 and K213037. It serves a clinic that sends patients with diabetes out for eye exams and would rather settle the question in the exam room.
The software roles differ as well. SKOUT assists an endoscopist who stays in charge of the procedure, and Digital Diagnostics says its system makes a diagnosis without physician input. Endoscopy groups are SKOUT's audience, and clinics screening diabetic patients are LumineticsCore's.
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.
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.
When to pick each one
Digital Diagnostics
- FDA De Novo in April 2018, two later 510(k)s
- Retinal photo diagnosis for diabetic patients
Iterative Health
- Colonoscopy polyp detection, six clearances under QNP
- Aimed at endoscopists and endoscopy centers
- No public price, demo request only
Score
Each row shows points earned of points available under the published rubric.
Digital Diagnostics
28of 100
Iterative Health
42of 100
| Dimension | Digital Diagnostics | Iterative Health | 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 | 0 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Iterative Health
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request 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
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
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Digital Diagnostics | Iterative Health |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2017 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
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