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
- 84% · fresh
- Computed at
- 2026-10-29T16:46:14.826519+00:00
- Claimed
- 85
- Reported
- 85
- Verified
- 80
- Gap
- +5
Public ambition and stated capability
Observed practitioner reporting
Independently supported evidence
Claimed leads verified
Evidence strength Strong
Decision
What the current evidence supports
Human editorial judgment · 2026-10-29
Proceed with caution
- Why
- The hardware is FDA-cleared (K261694, 2026-07-23), shipping since 2026-10-22 at $199, and the underlying AI software clearance (K251494, EFAST, 2025-08-12) predates it with peer-reviewed support from earlier Eko devices (JAHA 2021, 90% sensitivity / 91.4% specificity with grade 1 murmurs excluded). However, the CORE 300-specific and pediatric performance data are not public, the 2023 primary-care study was small (369 patients) and company-sourced, outcome benefit is unproven, and the AI requires a recurring subscription and is U.S.-only for now.
- Next
- Request Eko's K261694 and K251494 510(k) summaries and indications for use to confirm pediatric scope for the murmur AI, run a small local pilot with echocardiography as reference, and track independent validation and non-U.S. approvals.
Constraints
Blockers
No named blocker is present in the current public projection.
Evidence summary
Derived counts
AI-assisted assembly
- Total
- 10
- Tier 1
- 3
- Tier 2
- 3
- Tier 3
- 4
- Supports
- 6
- Contradicts
- 1
- Context
- 3
- Latest observed
- 2026-10-23
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.