Transparency · Regulatory intelligence
Regulatory Atlas Updates
A concise public ledger separating selection changes, evidence review, methodology changes, and presentation maintenance in the Neurosurgery AI Regulatory Atlas.
- Current version
- Atlas v1.3
- Public cases
- 10
- Selection review
- Sep 9, 2026
- Next review
- Oct 9, 2026
What this records
Material public changes to selection, evidence interpretation, methodology, and maintenance scope.
What this does not claim
The ledger begins with the public Atlas launch on September 8, 2026. It is not a complete history of the private registry or continuous monitoring.
Sep 17, 2026 · Presentation and provenance
Publication, page-update, evidence-search, and review dates separated
Added explicit date labels to public case records and standardized the reading template order.
- Evidence effect
- No source search, professional review, device evidence, clinical conclusion, or scheduled review date changed. September 17 is a page-maintenance date only.
Sep 10, 2026 · Presentation
Cross-case evidence matrix drafted
Added a compact comparison of function, pathway, public AI disclosure, strongest validation design, change control, and postmarket boundaries across the ten selected cases.
- Evidence effect
- No device evidence, selection decision, interpretation, or source-check date changed. The matrix reorganizes already reviewed public case material.
Sep 10, 2026 · Synthesis
Clinical-regulation pathway map drafted
Added a cross-case guide linking intended use, pathway, disclosed AI function, validation, human review, change control, and postmarket evidence.
- Evidence effect
- No device evidence, selection decision, or source-check date changed. The guide synthesizes the ten already selected public cases.
Sep 9, 2026 · Methodology
Dedicated public methodology added
Published the Atlas-specific rules for exact-submission joins, source hierarchy, AI disclosure, evidence classification, PCCP lineage, postmarket attribution, maintenance, and corrections.
- Evidence effect
- No device evidence or clinical claim changed. The ten public cases received methodology links only.
Sep 9, 2026 · Public selection
Atlas v1.1 expanded from eight to ten cases
Added Mazor X K251316 and SpineAR SNAP K252054 to show surgeon-reviewed AI planning and version-specific augmented-reality segmentation evidence.
- Evidence effect
- Two new source-checked cases were added. The underlying evidence reviews for the original eight cases were not silently advanced.
Sep 8, 2026 · Launch
Selective public Regulatory Atlas launched
Published eight representative FDA case studies from a private registry of 30 source-checked submissions, with function, pathway, evidence, AI-disclosure, PCCP, and postmarket boundaries.
- Evidence effect
- This was the first public selection, not publication of the private registry and not a claim of exhaustive market coverage.