icobrain aria
icometrix NVicobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.
Intended Use
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to detect, assess, and characterize Amyloid Related Imaging Abnormalities (ARIA) from brain MR images in Alzheimer's patients undergoing amyloid beta-directed antibody therapy.
Technology
The device uses deep learning to process 2D FLAIR images for ARIA-E detection and 2D T2*-GRE images for ARIA-H detection, automatically segmenting abnormalities and generating annotated DICOM images and electronic reports with severity scores derived from clinical trial data.
Performance
The software showed high sensitivity and specificity in detecting ARIA-E and ARIA-H in MRI scans, with a large clinical study showing significant improvement in radiologist performance when assisted by the software. Standalone and clinical testing demonstrated the device's effectiveness in improving diagnostic accuracy and reliability in safety monitoring of Alzheimer's patients under amyloid beta-directed antibody treatment.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/15/2024
7 months - 2
FDA Approval
11/7/2024
Other devices from icometrix NV
- icobrain-ctp2020 • 510K
- Icobrain2019 • 510K
- icobrain2018 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.