Imaging & Diagnostic AI · Assurance Record
qXR (Chest X-ray AI Suite)
Qure.ai · Hospital radiology and ED; community and public-health screening sites · Cloud SaaS and on-premise options; DICOM/PACS integration
Decision summary
- Suitable for
- Hospitals, radiology groups and teleradiology providers, public health and TB/lung cancer screening programs
- Documentary gate
- Failed
- Scenario match
- Matches this scenario — FDA-cleared imaging AI platforms
- Comparability
- Not yet comparable in this scenario
- Decision readiness
- HISTORICAL — Research only
- Documented evidence
- 0 of 6 evidence claims independently confirmed · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Last independent review
- not yet measured
regulatory filingopenFDA 510(k) database confirms Qure.ai qER head-CT triage clearance K200921 (decision 2020-06-17); company additionally reports six new qX…2026-02-26
Exact claim. 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.
- Source
- accessdata.fda.gov
- Type
- regulatory filing
- Published
- 2026-02-26
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
A regulatory listing confirms authorization status — not real-world effectiveness or economics.
Open accessdata.fda.govpress releaseCompleted a $65M Series D led by Lightspeed and 360 ONE Asset (Sept 2024); solutions deployed in 90+ countries across 3,000+ sites2024-09-25
Exact claim. Completed a $65M Series D led by Lightspeed and 360 ONE Asset (Sept 2024); solutions deployed in 90+ countries across 3,000+ sites
- Source
- globenewswire.com
- Type
- press release
- Published
- 2024-09-25
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- market_durability
- Score contribution
- Feeds market durability
Vendor or press announcement. Verify material claims against primary filings or contracts.
Open globenewswire.compress releaseCEO Prashant Warier states Qure.ai aims to reach profitability in the next financial year and pursue an IPO within roughly two years (May 20…2025-05-20
Exact claim. 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)
- Source
- m.economictimes.com
- Type
- press release
- Published
- 2025-05-20
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- market_durability
- Score contribution
- Feeds market durability
Vendor or press announcement. Verify material claims against primary filings or contracts.
Open m.economictimes.comvendor pageMaintains ISO/IEC 27001 certification and HIPAA compliance, ISO 13485 quality system, and multiple published FDA 510(k) summaries (qER K2009…2026-08-15
Exact claim. 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)
- Source
- qure.ai
- Type
- vendor page
- Published
- 2026-08-15
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- trust_governance
- Score contribution
- Feeds trust governance
Self-reported by the vendor. Independent verification is pending unless marked otherwise.
Open qure.aipeer reviewed studyProspective multi-centre study (Open Forum Infectious Diseases, 2026) of qXR version 3 AI-based chest X-ray screening across 3 public health…2026-05-01
Exact claim. 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).
- Source
- pmc.ncbi.nlm.nih.gov
- Type
- peer reviewed study
- Published
- 2026-05-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open pmc.ncbi.nlm.nih.govpeer reviewed studyMulti-country head-to-head accuracy comparison (Annals of the American Thoracic Society, 2026) of 7 automated chest X-ray algorithms on 3,90…2026-05-01
Exact claim. 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.
- Source
- doi.org
- Type
- peer reviewed study
- Published
- 2026-05-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open doi.orgVerified provider experience is not yet publishable. Fewer than five independent provider organizations have contributed eligible reviews. Reviewer mode is off. Experience never changes documentary scoring, freshness, or rank.
Buyer lenses — evidence-backed bands (not a 0–100 rank)
Deployment, integration, data handling
- Integration maturity
- none — No integration path on file.
- EHR path
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- FHIR / API
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- SSO
- UNKNOWN
Why unknown
Why. Single-sign-on support is not documented in vendor or marketplace materials on file.
What would close it. Vendor security documentation or marketplace listing mentioning SSO/SAML/OIDC.
- PHI / BAA
- HIPAA-compliant processing of imaging PHI; ISO/IEC 27001 certified; AES-256 encrypted pipelines · BAA available
- Security attestations
- ISO/IEC 27001, HIPAA, ISO 13485
- FDA status
- UNKNOWN
Why unknown
Why. No FDA listing found for this product's functions in the tracked category.
What would close it. An FDA 510(k)/De Novo listing, or a clear statement that no regulated function is claimed.
- Pricing
- Not publicly listed
Technical provenance
snap_8a8a4c9bb810aee3 · 2026-08-27T04:05Z · build 6a9fe1b
Forecast calibration is not in the public snapshot — shown as UNKNOWN rather than read from SQLite.
Known limitations
- Deployment traction is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Interoperability is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Economic value evidence is UNKNOWN.
Why unknown
Why. No independently verifiable ROI claim (peer-reviewed, audited case, or independent benchmark) is on file.
What would close it. An audited implementation report or peer-reviewed study with payback/throughput numbers.