1CMR Pro
Mycardium AI Limited1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.
Intended Use
1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. Compatible with 1.5T and 3T CMR.
Technology
1CMR Pro provides a user interface for viewing and analyzing cardiac MRI images using AI. It performs automated segmentation and quantification of cardiac structure and function using multi-parametric CMR images.
Performance
Clinical validation included non-clinical performance testing on independent datasets with 64 adults of mixed cardiac pathologies and multiple MRI scanners. Performance was superior or comparable to human experts in metrics such as DICE scores, accuracy, and precision. Precision testing on 110 adults showed AI superiority over human measurements and prior FDA-cleared software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/15/2024
4 months - 2
FDA Approval
11/15/2024
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