FerriSmart Analysis System
Resonance Health Analysis Services Pty LtdFerriSmart is a medical software that automatically analyzes MRI scans of the liver to measure iron concentration. This helps doctors diagnose and monitor patients with iron overload diseases, such as thalassemia or sickle cell disease, making treatment decisions more accurate and timely.
Intended Use
Measurement of R2 and iron concentration in the liver from MRI scans.
Technology
Stand-alone software application using convolutional neural networks for image recognition and analysis of multi-slice, spin-echo MRI data; performs automatic R2 measurement and converts to liver iron concentration using a calibration curve; includes an AI-based image quality control module.
Performance
Performance testing included software verification and validation, user usability testing, repeatability and clinical studies. Clinical study on 971 datasets showed sensitivities and specificities above 90% for clinically relevant liver iron concentration thresholds compared to the predicate device FerriScan. Repeatability was comparable or better than liver biopsy variability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/15/2018
3 months - 2
FDA Approval
11/30/2018
Other devices from Resonance Health Analysis Services Pty Ltd
- HepaFatSmart (V2.0.0)2023 • 510K
- LiverSmart2021 • 510K
- HepaFat-AI2020 • 510K
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