Cleerly vs Gleamer
Cleerly's openFDA records run under three product names. Cleerly Labs has decisions in November 2019 (K190868), October 2020, March 2025 and July 2026, Cleerly ISCHEMIA one in September 2023 and Cleerly Plaque one in July 2026. The vendor says its serial CCTA comparison tracks plaque change.
RadNet announced in March 2026 that it had acquired Gleamer for up to EUR 230M, to be integrated into DeepHealth. openFDA names BoneView, BoneMetrics and ChestView under the Gleamer name, the latest decision in September 2026, plus Pixyl.Neuro under Pixyl SA. The vendor also lists LungCT, BoneCT and BreastView, and the openFDA records under the Gleamer name do not show their US status.
Cleerly reads coronary CT angiograms and Gleamer reads emergency radiographs and chest films. A US imaging group adding AI would match Cleerly to cardiac CT and Gleamer to X-ray, each in its own reading room.
Radiology · Reviewed November 2, 2026
When to pick each one
Cleerly
- Cleerly Labs, ISCHEMIA and Plaque all named in openFDA
- Vendor says serial CCTA comparison tracks plaque change
Gleamer
- BoneView, BoneMetrics and ChestView named in openFDA
- Part of RadNet's DeepHealth since March 2026
- Vendor lists CT, MRI and mammography tools beyond X-ray
Score
Each row shows points earned of points available under the published rubric.
Cleerly
52of 100
Gleamer
56of 100
| Dimension | Cleerly | Gleamer | 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 | 18.2 / 18.2 | -5.5 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 0 / 7.8 | +3.9 |
| Funding & adoption signal | 6 / 12 | 8.4 / 12 | -2.4 |
| 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. |
Gleamer
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
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.
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)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Cleerly | Gleamer |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | FR |
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.


