Stealth AXiS Cranial clinical application
Medtronic Navigation
Cranial planning and stereotactic navigation, with image merging and generated tractography.
Evidence Nonclinical testing
AI tools · FDA evidence records
Neurosurgery.ai Index
Eight tools. What they do, what was tested, and where the evidence stops.
Inclusion is not endorsement. FDA clearance does not establish better patient outcomes. How we review
Regulatory intelligenceNeurosurgery AI Regulatory Atlas — 10 selected case studies showing what FDA established, what remains unproven, and what changed after authorization
Direct workflow
Operative intelligence
SafeOp 3: Neural Informatix System
Alphatec Spine
Intraoperative neurophysiological monitoring with automated SSEP baseline classification.
Evidence Nonclinical validation
Acorn 3D Software
Mighty Oak Medical
AI-assisted vertebral segmentation and patient-specific 3D spine planning.
Evidence Segmentation validation / bench testing
Stealth AXiS Spine clinical application
Medtronic Navigation
Spine navigation with AI-generated pedicle-screw plans and vertebral segmentation.
Evidence Nonclinical testing
Multidisciplinary workflow
Imaging and treatment planning
Cirrus Resting State fMRI Software
Sora Neuroscience
Resting-state fMRI correlation maps for adjunctive motor, language and vision mapping.
Evidence Patient-dataset validation
RT Elements 4.5
Brainlab
Cranial and spine stereotactic radiotherapy planning with AI-assisted segmentation.
Evidence Software / phantom testing
Viz Subdural+
Viz.ai
Quantifies subdural collections and midline shift on non-contrast CT, for physician review.
Evidence Retrospective two-site testing
Workflow-adjacent
Acute neurovascular triage
JLK-NCCT
JLK
Adult head-CT triage notifications for suspected intracranial hemorrhage or large-vessel occlusion; not primary diagnosis.
Evidence LVO dataset testing
About the evidence & update schedule
Clearance is the start of the review.
Each full record links to the original FDA dossier and separates intended use, testing, performance and clinical limitations. Dataset validation is not proof of patient benefit. This is a selected set, not a comprehensive directory; the FDA's AI-enabled device list is also non-comprehensive.
How this Index stays current.
Planned cadence: monthly safety scans, quarterly regulatory reviews, and six-monthly evidence reviews. Source-check dates are separate from original evidence dates. Major safety or indication changes receive earlier attention; this is not continuous surveillance.