Cleerly vs Digital Diagnostics
LumineticsCore is sold into primary care. The vendor names Cahaba Medical Care, Zufall Health and OSF HealthCare as customers and says exams bill under CPT 92229. Published studies of IDx-DR, its former name, vary. A 2025 systematic review and meta-analysis reports a pooled AUC of 0.95, while a 2026 Scientific Reports real-world comparison with ophthalmologist fundoscopy grading found a 54.2% exact match and 4.8% undergrading.
Cleerly reads coronary CTA studies, and the vendor describes output covering plaque volume, composition, length and location, stenosis and ischemia likelihood. Per its coverage page, AMA CPT Category I code 75577 took effect in January 2026. Cleerly's press release lists UnitedHealthcare, Cigna and Humana among payers and says Aetna requires an FDA-cleared platform. Cleerly says it integrates with PowerScribe. Cardiology services and imaging groups with a CCTA program are its users.
In a health system with a CCTA program and a diabetic primary care panel, cardiology would own one tool and primary care the other.
Radiology · Reviewed November 2, 2026

Cleerly
by Cleerly
AI-driven CCTA plaque quantification + CAD staging.

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
Cleerly
- Coronary CTA plaque, stenosis and ischemia likelihood, per vendor
- Cleerly says it integrates with PowerScribe
- Cleerly says CPT Category I code 75577 began January 2026
Digital Diagnostics
- Vendor says exams bill under CPT 92229
- Vendor-named customers include Cahaba and Zufall
- Studies of IDx-DR, its former name, range widely
Score
Each row shows points earned of points available under the published rubric.
Cleerly
52of 100
Digital Diagnostics
28of 100
| Dimension | Cleerly | 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 | 12.7 / 18.2 | 0 / 18.2 | +12.7 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 0 / 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
Cleerly
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage offers a demo request. |
Digital Diagnostics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Cleerly
FDA decisions
K260588 (opens in new tab)510(k)2026-07-29
Cleerly LABS
K261210 (opens in new tab)510(k)2026-07-29
Cleerly Plaque
K242338 (opens in new tab)510(k)2025-03-07
Cleerly LABS (v2.0)
K231335 (opens in new tab)510(k)2023-09-08
Cleerly ISCHEMIA
K202280 (opens in new tab)510(k)2020-10-02
Cleerly Labs v2.0
Show 1 more
K190868 (opens in new tab)510(k)2019-11-05
Cleerly Labs
Peer-reviewed
2 PubMed records name Cleerly.
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 | Cleerly | 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
Open the full radiology comparison
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.
