Verification register Bio, Health & Neuro
Current reading
The readiness gap, in one scan
AI-assisted assembly · derived results
- Claimed
- 85
- Reported
- 84
- Verified
- 76
- Gap
- +9
Public ambition and stated capability
Observed practitioner reporting
Independently supported evidence
Claimed minus verified
Evidence strength Growing
Decision
What the current evidence supports
Human editorial judgment · 2026-06-28
Adopt with guardrails
- Why
- FDA-cleared (Jan 2024) and commercially live with a strong sham-controlled PDN signal (72.3% responder at day 30 vs 0% sham, p<0.0001), but the evidence base is thin (one small pivotal trial) and durability depends on recurring treatment.
- Next
- Track post-market PDN data and any second pivotal RCT; treat single-trial responder rates as provisional and require sham-controlled replication before citing efficacy externally. Watch CMS coverage outcome.
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
- 1
- Tier 3
- 4
- Supports
- 4
- Contradicts
- 1
- Context
- 2
- Latest observed
- 2025-05-02
Counts and dates only. Raw signals, private excerpts, trust records, and internal corpus material are not published here.
Publication record
Revisions
Initial public reading
This is the initial public reading. No earlier readiness change is recorded.