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
- 63% · fresh
- Computed at
- 2026-08-20T10:56:07.810359+00:00
- Claimed
- 90
- Reported
- 86
- Verified
- 78
- Gap
- +12
Public ambition and stated capability
Observed practitioner reporting
Independently supported evidence
Claimed leads verified
Evidence strength Critical
Decision
What the current evidence supports
Human editorial judgment · 2026-08-20
Proceed with caution
- Why
- The FDA clearance is real and dated 2026-08-11 — a genuine industry-first for standalone AI-assisted QC software in clinical pathology, backed by Leica's dominant installed base (~2M cancer tests/week, 100% of Top 50 US cancer hospitals) — but the RUO-labeled GT Elite scanner named in the candidate is not itself part of the cleared bundle, and the flagship performance numbers are single-site, vendor-sourced.
- Next
- Confirm the exact FDA-cleared SKU list (iQC DX / GT 180 DX / enhanced GT 450 DX) before citing GT Elite itself as FDA-cleared, and track independent multi-site validation of the 24%-more-artifacts / 69%-faster-review figures before raising readiness confidence.
Constraints
Blockers
No named blocker is present in the current public projection.
Evidence summary
Derived counts
AI-assisted assembly
- Total
- 5
- Tier 1
- 0
- Tier 2
- 2
- Tier 3
- 3
- Supports
- 3
- Contradicts
- 1
- Context
- 1
- Latest observed
- 2026-08-17
Counts and dates only. Raw signals, private excerpts, trust records, and internal corpus material are not published here.
Publication record
Revisions
Initial public reading
- 2026-08-17 Reading moved from mature to mature.