Imaging & Diagnostic AI · Assurance Record
Cleerly Coronary Analysis
Cleerly · Outpatient cardiology · Cloud analysis + physician review
Decision summary
- Suitable for
- Cardiology practices, health systems, prevention 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 2 evidence claims independently confirmed · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Last independent review
- not yet measured
independent reportMedicare coverage pathway established via new CPT Category I codes for quantitative coronary plaque analysis (2026).2026-01-01
Exact claim. Medicare coverage pathway established via new CPT Category I codes for quantitative coronary plaque analysis (2026).
- Source
- ama-assn.org
- Type
- independent report
- Published
- 2026-01-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- deployment_traction
Independent source. Methodology and sample vary by report; read the underlying method.
Open ama-assn.orgpeer reviewed studyCERTAIN study (European Heart Journal - Cardiovascular Imaging, 2024): in 750 consecutive patients at 5 expert CCTA sites, Cleerly AI-QCT an…2024-06-01
Exact claim. 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.
- Source
- pmc.ncbi.nlm.nih.gov
- Type
- peer reviewed study
- Published
- 2024-06-01
- 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.govVerified 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
- announced — Announced or documented integration; marketplace listing not confirmed.
- EHR path
- DICOM/PACS, structured reporting to EHR
- 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
- BAA; imaging + derived reports · BAA available
- Security attestations
- HIPAA
- FDA status
- CLEARED
- 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.
- 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.