Myomics
Phantomics Inc.Myomics is a software tool designed to assist clinicians in viewing, processing, and quantitatively analyzing cardiovascular magnetic resonance (MR) images. Using AI-powered algorithms, it helps in detailed assessment of heart structures and adjacent vessels to support diagnosis in adult patients based on images acquired from 3.0 T MR scanners.
Intended Use
Viewing, post-processing, qualitative and quantitative evaluation of blood vessels and cardiovascular MR images in DICOM format.
Technology
Myomics uses AI-powered semi-automatic segmentation algorithms to analyze cardiac MR images from 3.0 T scanners, with modules trained and validated on large datasets. It operates as standalone or integrated software and complies with DICOM and other medical imaging standards.
Performance
Bench testing confirmed functional equivalence with predicate devices including image import, display, contour drawing and semi-automatic segmentation. AI performance testing used 728 anonymized MR cases from multiple vendors with all modules achieving DICE scores above 0.7, meeting predefined acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2024
8 months - 2
FDA Approval
2/28/2025
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