LVivo Seamless
DiA Imaging Analysis Ltd.LVivo Seamless is a software platform designed to automatically process echocardiogram ultrasound images to detect, measure, and calculate important cardiac medical parameters. It helps clinicians by selecting the appropriate image clips and activating AI modules to evaluate ejection fraction (EF) and global longitudinal strain (GLS), improving workflow and providing quantitative cardiac function data for better diagnosis and monitoring.
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 and Age >18.
Technology
The LVivo Seamless is a standalone offline application that accepts echocardiogram DICOM images for automatic clip selection and activates automated evaluation modules for EF and strain, including FDA cleared LVivo EF, LVivo Strain, and third-party software for analysis. It outputs results to PACS for clinician review.
Performance
Performance testing involved 166 echocardiogram exams with diverse patient demographics and devices. Automatic processing success rate achieved 85%, with at least 80% correlation to ground truth measurements for biplane EF and GLS. Statistical analyses (Pearson correlation and Bland-Altman) confirmed performance comparable to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2024
4 months - 2
FDA Approval
3/6/2025
Other devices from DiA Imaging Analysis Ltd.
- LVivo Software Application2025 • 510K
- LVivo Software Application2025 • 510K
- LVivo Software Application2024 • 510K
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