Every claim we hold, and how far we can stand behind it.
142 claims across 39 products. 30% are confirmed against the source text by the evidence gate; 39% come from a class with no vendor interest. Everything below is browsable, filterable, and available as JSON.
| Evidence class | Claims | Confirmed | What it can support |
|---|---|---|---|
| Peer-reviewed study | 19 | 5 | Independent review before publication. The only class that survives a sceptical committee unaided. |
| Regulatory filing | 4 | 0 | A statement made to a regulator, where being wrong has consequences. |
| Independent report | 32 | 9 | Analysis by someone with no stake in the sale. |
| Customer case | 4 | 3 | A real deployment, but selected and framed by someone with an interest. |
| Press release | 63 | 23 | The vendor's own announcement. Useful for dates and facts, not for outcomes. |
| Vendor page | 20 | 2 | Marketing copy. Establishes what is claimed, never that it is true. |
Showing 4 of 4 matching claims (142 in the full corpus) · 0% of this selection is confirmed · clear filters
Multiple FDA 510(k) clearances listed on the FDA AI-enabled medical device list for triage algorithms (ICH, PE, C-spine, AA).
Provenance
- Claim ID
- clm_5d780a0a0db46f085b4e
- Version
- 1
- Workflow
- Imaging & Diagnostic AI
- Dimension
- trust governance
- Retrieved
- 2026-08-27
- Reviewer
- healthit-gate-v1
- Source URL
- https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
Lunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.
Provenance
- Claim ID
- clm_36a86ca26ff6e1e2f3cd
- Version
- 1
- Workflow
- Imaging & Diagnostic AI
- Dimension
- trust governance
- Retrieved
- 2026-08-27
- Reviewer
- healthit-gate-v1
- Source URL
- https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
Multiple FDA clearances for stroke imaging listed on FDA AI device list; the most-cited CTP platform in stroke trials.
Provenance
- Claim ID
- clm_89ce522c902ca998dc94
- Version
- 1
- Workflow
- Imaging & Diagnostic AI
- Dimension
- trust governance
- Retrieved
- 2026-08-27
- Reviewer
- healthit-gate-v1
- Source URL
- https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
Medicare coverage pathway established via new CPT Category I codes for quantitative coronary plaque analysis (2026).
Provenance
- Claim ID
- clm_214493e1ea1a8f8cd8f7
- Version
- 1
- Workflow
- Imaging & Diagnostic AI
- Dimension
- deployment traction
- Retrieved
- 2026-08-27
- Reviewer
- healthit-gate-v1
- Source URL
- https://www.ama-assn.org/practice-management/cpt