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 8 of 8 matching claims (142 in the full corpus) · 0% of this selection is confirmed · clear filters

Maintains ISO/IEC 27001 certification and HIPAA compliance, ISO 13485 quality system, and multiple published FDA 510(k) summaries (qER K200921, qXR-PTX-PE K230899, qCT-Quant K240740, qER-Quant K211222, qXR-BT K212690, qXR-CTR K231149)
qXR (Chest X-ray AI Suite)Vendor pageUnverified2026-08-15Open source ↗
Provenance
Claim ID
clm_bfede745158ca4d072d0
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
trust governance
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://www.qure.ai/us/regulatory-and-privacy
Prospective multi-centre study (Open Forum Infectious Diseases, 2026) of qXR version 3 AI-based chest X-ray screening across 3 public health facilities in Chhattisgarh, India: of 2,745 CXRs screened, 363 patients were presumptive for TB and 162 confirmed cases were found (44.63% positivity among presumptive cases), and an 80.21% increase in TB case notifications was observed during the AI-implemented period versus baseline (P < .001).
qXR (Chest X-ray AI Suite)Peer-reviewed studyUnverified2026-05-01Open source ↗
Provenance
Claim ID
clm_326a114cde5f51400f91
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
evidence strength
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://pmc.ncbi.nlm.nih.gov/articles/PMC12810203/
Multi-country head-to-head accuracy comparison (Annals of the American Thoracic Society, 2026) of 7 automated chest X-ray algorithms on 3,901 chest X-rays from India, Madagascar, the Philippines, South Africa, Tanzania, Uganda, and Vietnam found qXR achieved the WHO minimum target accuracy for a tuberculosis triage test (>=90% sensitivity with >=70% specificity), with specificity of 70% or greater at 90% sensitivity.
qXR (Chest X-ray AI Suite)Peer-reviewed studyUnverified2026-05-01Open source ↗
Provenance
Claim ID
clm_36833a1aa15ec821791a
Version
1
Workflow
Imaging & Diagnostic AI
Dimension
evidence strength
Retrieved
2026-08-27
Reviewer
healthit-gate-v1
Source URL
https://doi.org/10.1093/annalsats/aaoag011
Multiple FDA 510(k) clearances listed on the FDA AI-enabled medical device list for triage algorithms (ICH, PE, C-spine, AA).
Aidoc aiOSIndependent reportUnverified2026-03-27Open source ↗
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.
Lunit INSIGHTIndependent reportUnverified2026-03-26Open source ↗
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.
Rapid CTAIndependent reportUnverified2026-03-20Open source ↗
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
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
Medicare coverage pathway established via new CPT Category I codes for quantitative coronary plaque analysis (2026).
Cleerly Coronary AnalysisIndependent reportUnverified2026-01-01Open source ↗
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

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