Gleamer vs Lunit
Breast screening is the clearest overlap. Lunit's INSIGHT MMG (K211678, November 2021, with v1.1.10 as K260320 in April 2026) and INSIGHT DBT for tomosynthesis (K231470, with updates K242652 and K253796) are on openFDA, and Lunit completed its Volpara purchase in May 2024 for about US$193M. Gleamer's page lists BreastView for mammography, and its US status is not established. A US breast screening program has Lunit's openFDA records to go on, which makes Gleamer the weaker pick for that buyer.
Lunit says its FDA-cleared and CE-marked products run at 10,000+ sites in 70+ countries, and Gleamer says 3,500+ clinical sites in 50+ countries. Both are vendor figures. Lunit takes inquiries through a contact form and Gleamer through demo requests, with no public price from either.
An emergency or orthopedic imaging service buys Gleamer for BoneView, whose two clearances (March 2022 and March 2023) are for fracture and bone-trauma detection on X-ray.
Radiology · Reviewed November 2, 2026
Gleamer
by Gleamer SAS
Radiology AI for fracture and chest X-ray findings, plus CT, MRI and mammography; part of RadNet DeepHealth since March 2026.
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
Gleamer
- BoneView fracture reads on X-ray
- ChestView US records K241620 and K252486
- Systematic review of BoneView fracture detection
Lunit
- INSIGHT MMG and DBT for breast screening
- Volpara density tools since the 2024 acquisition
- Vendor lists INSIGHT CXR TB screening and normal flagging
Score
Each row shows points earned of points available under the published rubric.
Gleamer
56of 100
Lunit
66of 100
| Dimension | Gleamer | Lunit | 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 | 18.2 / 18.2 | 12.7 / 18.2 | +5.5 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Gleamer
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
Lunit
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Contact form only. |
Evidence
Gleamer
FDA decisions
K252486 (opens in new tab)510(k)2026-09-09
ChestView US (1.1)
K241620 (opens in new tab)510(k)2025-02-27
ChestView US
K241593 (opens in new tab)510(k)2025-02-05
BoneMetrics (US)
K213253 (opens in new tab)510(k)2023-06-30
Pixyl.Neuro
K222176 (opens in new tab)510(k)2023-03-02
BoneView
Show 1 more
K212365 (opens in new tab)510(k)2022-03-01
BoneView
Peer-reviewed
5 PubMed records name Gleamer.
- Opinion paper: artificial intelligence as a clinical ally in lung cancer detection-the case for Gleamer's ChestView. (opens in new tab)
- AI model for automatic spinopelvic and spinal alignment parameters measurement from EOS. (opens in new tab)
- Fracture Detection on Bone Radiographs: The Impact of an AI Tool on Orthopaedic Night Shifts. (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 | Gleamer | Lunit |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2013 |
| HQ | FR | KR |
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.