Verification register Bio, Health & Neuro
Current reading
Readiness band and full integer triple
AI-assisted assembly · derived results
Readiness band
Mature
Primary summary from verified readiness
- Confidence
- 78% · fresh
- Computed at
- 2026-10-29T16:46:17.902258+00:00
- Claimed
- 85
- Reported
- 85
- Verified
- 85
- Gap
- 0
Public ambition and stated capability
Observed practitioner reporting
Independently supported evidence
Claimed and verified align
Evidence strength Strong
Decision
What the current evidence supports
Human editorial judgment · 2026-10-29
Proceed with caution
- Why
- FFR-IQ is a genuinely FDA-cleared (Class II, PJA) AI-based FFR-CT that estimates physiology from a single coronary CTA by integrating plaque composition via Plaque-IQ rather than CFD, and reports 92.2% sensitivity and 93.1% specificity per vessel against invasive FFR. Evidence is a single retrospective multicenter study with exclusions (prior CABG/PCI/MI) and a predicate-comparison framing; the 'most accurate' claim is vendor-asserted and cross-study, and a lawsuit from the predicate vendor was filed one day after the launch announcement. Real-world adoption and reimbursement uptake are unproven.
- Next
- Review the TCT 2026 (Nov 1) ELUCIDATE presentation, watch for peer-reviewed publication and the Heartflow litigation, and compare head-to-head or prospective data against established FFR-CT before any procurement.
Constraints
Blockers
No named blocker is present in the current public projection.
Evidence summary
Derived counts
AI-assisted assembly
- Total
- 7
- Tier 1
- 2
- Tier 2
- 0
- Tier 3
- 5
- Supports
- 4
- Contradicts
- 0
- Context
- 3
- Latest observed
- 2026-10-28
Counts and dates only. Raw signals, private excerpts, trust records, and internal corpus material are not published here.
Publication record
Revisions
Initial public reading
- 2026-10-29 Initial recorded band: mature.