LVivo Seamless
DiA Imaging Analysis LtdLVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.
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
Standalone software application running offline on a server, accepting DICOM clips from ultrasound devices, automatically selecting adequate clips for EF and GLS evaluation, and activating modules LVivo EF and LVivo Strain for automatic evaluation. Results are sent to PACS for clinician review.
Performance
Performance evaluation on 100 patient examinations showed 95% accuracy in automatic identification of cardiac views, and GLS measurement correlation of 0.88 with reference standard. Sensitivity and specificity for GLS abnormality classification were 0.90 and 0.83 respectively, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/6/2021
4 months - 2
FDA Approval
12/9/2021
Other devices from DiA Imaging Analysis Ltd
- LVivo Software Application2024 • 510K
- LVivo IQS2024 • 510K
- LVivo IQS2023 • 510K
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