Brainomix 360 e-ASPECTS
Brainomix LimitedBrainomix 360 e-ASPECTS is an AI-based software that analyzes non-contrast CT brain scans to help clinicians assess ischemic brain tissue injury and calculate an ASPECTS score, which reflects the extent of stroke-related brain damage. It uses automated image processing and machine learning to highlight affected brain regions, providing decision support for stroke diagnosis and treatment.
Intended Use
Brainomix 360 e-ASPECTS is a CADx software device to assist clinician in assessment and characterization of brain tissue abnormalities using CT image data, providing an ASPECTS score to aid ischemic stroke evaluation within 24 hours of last known well.
Technology
Software uses machine learning to automatically register and segment NCCT brain images, extract voxel image data, and generate heatmaps of affected ASPECTS regions, providing an automated ASPECTS score and visualizations, integrated with PACS and notification systems.
Performance
Validation includes digital phantom testing demonstrating accurate volumetric calculations, standalone performance with 137 NCCT stroke patient scans showing high AUC (83%), a multiple reader multiple case study proving improved reader performance with the software (AUC improvement from 78% to 85%), and risk management and cybersecurity compliance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/18/2024
3 months - 2
FDA Approval
2/14/2025
Other devices from Brainomix Limited
- Brainomix 360 e-Lung2025 • 510K
- Brainomix 360 e-CTA2025 • 510K
- Brainomix 360 Triage Stroke2023 • 510K
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