Eyenuk vs Lunit
Lunit sells chest X-ray and breast imaging AI and Eyenuk sells retinal screening, so a radiology department or breast center buys Lunit and a diabetes clinic that photographs retinas buys Eyenuk. INSIGHT CXR holds a Triage clearance (K211733, November 10, 2021), INSIGHT MMG's latest is K260320 (v1.1.10, April 23, 2026), and INSIGHT DBT's latest is K253796 (V1.2, March 26, 2026). Radiology Business put the Volpara acquisition, completed in May 2024, at about US$193 million. Lunit's own timeline says the WHO recommended it as a TB screening tool. A 2023 Diagnostics prospective multicenter study of 4,752 cases found an AUC of 0.84 for a Lunit product against 0.94 retrospectively, and an independent 2025 PLOS Digital Health comparison found a newer INSIGHT CXR version less accurate for TB reading until its threshold was recalibrated.
Eyenuk's evidence includes a 2021 British Journal of Ophthalmology prospective evaluation of EyeArt in English screening of 30,000 patients and a 2021 JAMA Network Open multicenter prospective evaluation of autonomous detection of referable and vision-threatening DR. The vendor says over 90% of patients get conclusive results without dilation.
Radiology · Reviewed November 2, 2026
Eyenuk
by Eyenuk, Inc.
EyeArt is FDA-cleared autonomous AI that grades diabetic retinopathy from retinal photos, with no physician overread needed.
Lunit
by Lunit · founded 2013
AI for chest X-ray, mammography and breast tomosynthesis, Volpara breast-density tools, and pathology biomarker software (SCOPE).
When to pick each one
Eyenuk
- 2021 English screening evaluation of 30,000 patients
- Vendor says over 90% conclusive without dilation
Lunit
- Chest X-ray, mammography and tomosynthesis reading aids
- INSIGHT DBT latest K253796, March 26, 2026
- MDR CE and UKCA marks, announced November 2022
Score
Each row shows points earned of points available under the published rubric.
Eyenuk
71of 100
Lunit
66of 100
| Dimension | Eyenuk | Lunit | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 10 | +10 |
| 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 | 18.2 / 18.2 | 12.7 / 18.2 | +5.5 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 7.8 / 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
Eyenuk
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Lunit
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Contact form only. |
Evidence
Eyenuk
FDA decisions
K223357 (opens in new tab)510(k)2023-06-16
EyeArt v2.2.0
K200667 (opens in new tab)510(k)2020-08-03
EyeArt
Peer-reviewed
5 PubMed records name Eyenuk.
- Diagnostic Accuracy of the EyeArt Artificial Intelligence System for Diabetic Retinopathy: A Systematic Review and Meta-Analysis. (opens in new tab)
- A pilot cost-analysis study comparing AI-based EyeArt® and ophthalmologist assessment of diabetic retinopathy in minority women in Oslo, Norway. (opens in new tab)
- [Use of Artificial Intelligence in Diabetic Retinopathy Screening: Experience in a Health Service in Santiago, Chile]. (opens in new tab)
Lunit
FDA decisions
K260320 (opens in new tab)510(k)2026-04-23
Lunit INSIGHT MMG (v1.1.10)
K253796 (opens in new tab)510(k)2026-03-26
Lunit INSIGHT DBT (V1.2)
K242652 (opens in new tab)510(k)2024-10-04
Lunit INSIGHT DBT v1.1
K231470 (opens in new tab)510(k)2023-11-06
Lunit INSIGHT DBT
K211678 (opens in new tab)510(k)2021-11-17
Lunit INSIGHT MMG
Show 3 more
K211733 (opens in new tab)510(k)2021-11-10
Lunit INSIGHT CXR Triage
K211279 (opens in new tab)510(k)2021-07-27
Volpara Imaging Software
K182310 (opens in new tab)510(k)2018-09-21
Volpara Imaging Software
Peer-reviewed
3 PubMed records name Lunit.
- Comparison of different Lunit INSIGHT CXR software versions when reading chest radiographs for tuberculosis. (opens in new tab)
- Genomic and transcriptomic analyses of residual invasive triple-negative breast cancer after neoadjuvant chemotherapy in the prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab plus capecitabine compared to capecitabine; KCSG-BR18-21). (opens in new tab)
- Long-term prognostic implications of AI-detected versus AI-undetected breast cancers on mammography: a propensity score-matched analysis. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Eyenuk | Lunit |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2013 |
| HQ | US | KR |
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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.