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RESEARCH PREVIEW · 2026-08-27
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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 classClaimsConfirmedWhat it can support
Peer-reviewed study195Independent review before publication. The only class that survives a sceptical committee unaided.
Regulatory filing40A statement made to a regulator, where being wrong has consequences.
Independent report329Analysis by someone with no stake in the sale.
Customer case43A real deployment, but selected and framed by someone with an interest.
Press release6323The vendor's own announcement. Useful for dates and facts, not for outcomes.
Vendor page202Marketing copy. Establishes what is claimed, never that it is true.

Showing 19 of 19 matching claims (142 in the full corpus) · 0% of this selection is confirmed · clear filters

  1. 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 pageUnverifiedOpen 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

  2. 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 studyUnverifiedOpen 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/

  3. 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 studyUnverifiedOpen 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

  4. Multiple FDA 510(k) clearances listed on the FDA AI-enabled medical device list for triage algorithms (ICH, PE, C-spine, AA).

    Aidoc aiOSIndependent reportUnverifiedOpen 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

  5. Lunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.

    Lunit INSIGHTIndependent reportUnverifiedOpen 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

  6. Multiple FDA clearances for stroke imaging listed on FDA AI device list; the most-cited CTP platform in stroke trials.

    Rapid CTAIndependent reportUnverifiedOpen 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

  7. 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 filingUnverifiedOpen 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

  8. Medicare coverage pathway established via new CPT Category I codes for quantitative coronary plaque analysis (2026).

    Cleerly Coronary AnalysisIndependent reportUnverifiedOpen 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

  9. Real-world performance evaluation of the Aidoc Medical Briefcase ICH Triage model across 101,944 non-contrast head CT examinations from 74,142 patients in a 17-facility academic health system (April 2023-April 2025) demonstrated 82.2% sensitivity, 97.6% specificity, and 96.6% accuracy for intracranial hemorrhage detection (npj Digital Medicine).

    Aidoc aiOSPeer-reviewed studyUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_c0fa19558e3ea5d6059f
    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/PMC12823562/

  10. Meta-analysis of six retrospective real-world studies encompassing 9,102 CTPA scans, all assessing the Aidoc or CINA-PE FDA-approved algorithms for acute pulmonary embolism detection, found pooled sensitivity of 93% (95% CI 88%-95%) and specificity of 98% (95% CI 93%-100%) (Cureus).

    Aidoc aiOSPeer-reviewed studyUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_15d57030cdd4dbabf213
    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/PMC12604435/

  11. CEO Prashant Warier states Qure.ai aims to reach profitability in the next financial year and pursue an IPO within roughly two years (May 2025)

    qXR (Chest X-ray AI Suite)Press releaseUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_feb6e7535e4e9cab9d13
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    market durability
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://m.economictimes.com/tech/artificial-intelligence/healthcare-ai-startup-qure-ai-aiming-for-ipo-in-two-years-ceo-says/articleshow/121286035.cms

  12. Completed a $65M Series D led by Lightspeed and 360 ONE Asset (Sept 2024); solutions deployed in 90+ countries across 3,000+ sites

    qXR (Chest X-ray AI Suite)Press releaseUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_9db738bc406a8512a625
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    market durability
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://www.globenewswire.com/news-release/2024/09/25/2953204/0/en/Global-healthcare-AI-innovator-Qure-ai-completes-65-million-Series-D-funding-round-led-by-Lightspeed-and-360One-Asset.html

  13. CERTAIN study (European Heart Journal - Cardiovascular Imaging, 2024): in 750 consecutive patients at 5 expert CCTA sites, Cleerly AI-QCT analysis improved physicians' confidence two- to five-fold at every step of the care pathway, changed diagnosis or management in 57.1% (428) of patients (P<0.001), and reduced the need for downstream non-invasive and invasive testing by 37.1% (P<0.001) versus conventional visual CCTA interpretation.

    Cleerly Coronary AnalysisPeer-reviewed studyUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_a7d0185737df3457a3b3
    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/PMC11139521/

  14. Completed SOC 2 Type II and HIPAA audits for the Viz.ai One Platform, marking the fourth consecutive year of SOC 2 Type II compliance

    Viz.ai One PlatformPress releaseUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_475a430afcb48493c9c8
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    trust governance
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://www.viz.ai/news/viz-ai-announces-successful-completion-of-soc-2-type-ii-hipaa-audits-for-viz-ai-one-platform

  15. 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 filingUnverifiedOpen 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

  16. Lunit INSIGHT MMG (Lancet Digital Health 2020): the AI algorithm was developed and validated on 170,230 mammography examinations from five institutions; in a multicentre, observer-blinded reader study of 320 mammograms read by 14 radiologists, AI performance (AUROC 0.940) significantly exceeded radiologists without assistance (AUROC 0.810, p<0.0001), and AI assistance improved radiologists' performance to AUROC 0.881 (p<0.0001).

    Lunit INSIGHTPeer-reviewed studyUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_9953a345495ad65fe703
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    evidence strength
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://doi.org/10.1016/S2589-7500(20)30003-0

  17. In 477 consecutive stroke-suspected CTAs, the RAPID CTA automated large vessel occlusion detection algorithm achieved sensitivity of 0.94 and negative predictive value of 0.98 with a median processing time of 158 seconds (IQR 150-167) (Stroke, 2019).

    Rapid CTAIndependent reportUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_cd32fe4c0f632177ad86
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    evidence strength
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://www.ahajournals.org/doi/10.1161/STROKEAHA.119.026259

  18. 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 filingUnverifiedOpen 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

  19. PLATFORM trial (JACC 2015): in 584 patients with suspected coronary disease, FFRCT-guided care reduced mean total medical costs by 32% in the planned-invasive stratum versus usual care ($7,343 vs $10,734; p<0.0001) over 90-day follow-up.

    HeartFlow Analysis (FFRct)Peer-reviewed studyUnverifiedOpen source ↗
    Provenance
    Claim ID
    clm_d313d88fef3ff93bd06f
    Version
    1
    Workflow
    Imaging & Diagnostic AI
    Dimension
    evidence strength
    Retrieved
    2026-08-27
    Reviewer
    healthit-gate-v1
    Source URL
    https://doi.org/10.1016/j.jacc.2015.09.051
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