Brainomix 360 e-CTA
Brainomix LimitedBrainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.
Intended Use
Brainomix 360 e-CTA is an image processing software package to be used by trained professionals to perform image viewing, processing, and analysis of CTA images.
Technology
Brainomix 360 e-CTA uses AI/ML algorithms to improve vessel detection by distinguishing bone from vessels and reducing image grain. It provides visualization with a 3D-colored overlay to show vessel density asymmetry between brain hemispheres. It connects with PACS and DICOM compliant devices, operating on standard off-the-shelf hardware or virtual servers.
Performance
Performance testing demonstrated that Brainomix 360 e-CTA accurately delineates vessels with high Dice Similarity Scores (~0.955) across 308 clinical CTA scans from diverse sources. AI/ML algorithm improvements reduced mean absolute error versus predicate device. Testing included phantom validation and retrospective clinical retrospective studies showing the device is safe, effective, and slightly improves performance relative to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/19/2024
5 months - 2
FDA Approval
1/6/2025
Other devices from Brainomix Limited
- Brainomix 360 Triage Stroke2023 • 510K
- Brainomix 360 Triage LVO2023 • 510K
- Brainomix 360 Triage ICH2023 • 510K
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