AI4CMR v1.0
AI4MedImaging Medical Solutions S.A.AI4CMR v1.0 is a software tool that uses artificial intelligence to automatically analyze cardiac MRI scans to measure cardiac function parameters like ventricle volumes and ejection fraction. It helps clinicians by providing automated quantification of cardiac metrics from MR images, improving workflow efficiency and supporting clinical decisions when integrated into a DICOM viewer.
Intended Use
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
Technology
AI4CMR v1.0 is a cloud-hosted service used as a plug-in in third-party DICOM viewer applications to automatically process and analyze cardiac MR images and quantify cardiac function metrics like ventricle volumes, ejection fraction, and myocardial mass using artificial intelligence segmentation.
Performance
Performance testing included standalone software validation on an external Society of Cardiac Magnetic Resonance (SCMR) consensus dataset showing good myocardial segmentation and cardiac metrics agreement with expert readers (e.g., dice similarity coefficient of 0.72 for segmentation, ICCs 0.78-0.99 for cardiac parameters). Clinical retrospective multi-reader multi-center study on 146 CMR cases showed excellent agreement between AI and expert readers for volumes, ejection fraction, and LV mass, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/3/2022
4 months - 2
FDA Approval
7/22/2022
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