LVivo Software Application
DiA Imaging Analysis Ltd.The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.
Intended Use
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. It also provides Quality Score feedback.
Technology
The LVivo platform analyzes DICOM ultrasound movies using automated AI algorithms for global and segmental evaluation of the left ventricle by ejection fraction and strain, supports right ventricular function evaluation, and bladder volume measurement. It includes modules for contrast agent processing and various apical views, enabling automated frame selection, manual adjustments, and visualization of cardiac function.
Performance
Performance testing included evaluation on 101 patient exams across varied LV function levels. Automated results showed high correlation (r>0.93) with manual measurements by sonographers for end-diastolic volume, end-systolic volume, and ejection fraction across multiple apical views, demonstrating accuracy and reliability. 90% of exams were automatically processed successfully without need for cardiologist modification.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/10/2024
4 months - 2
FDA Approval
3/3/2025
Other devices from DiA Imaging Analysis Ltd.
- LVivo Software Application2025 • 510K
- LVivo Seamless2025 • 510K
- LVivo Software Application2024 • 510K
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