Evidence explorer

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.

What this corpus is made of

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 3 of 3 matching claims (142 in the full corpus) · 0% of this selection is confirmed · clear filters

openFDA 510(k) database confirms Qure.ai qER head-CT triage clearance K200921 (decision 2020-06-17); company additionally reports six new qXR-Detect indications cleared Feb 2026.
qXR (Chest X-ray AI Suite)Regulatory filingUnverified2026-02-26Open source ↗
Provenance
Claim ID
clm_1e835f1c8fccd84f7260
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
evidence strength
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K200921
HeartFlow Analysis (FFRct) cleared via 510(k) K213857 on Oct 14, 2022 as an AI-based coronary vascular physiologic simulation software device (Class II, product code PJA)
HeartFlow Analysis (FFRct)Regulatory filingUnverified2022-10-14Open source ↗
Provenance
Claim ID
clm_46d1dda7a456af4d6efb
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
evidence strength
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213857
FDA granted the first-ever De Novo clearance for an AI computer-aided triage and notification platform (Viz LVO, Feb 2018), creating a new regulatory classification for AI triage software
Viz.ai One PlatformRegulatory filingUnverified2018-02-14Open source ↗
Provenance
Claim ID
clm_2f6a2acfe7387eae2d83
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
evidence strength
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-clinical-decision-support-software-alerting-providers-potential-stroke

Know a source we are missing?