LVivo Software Application
DIACARDIO, LTD.The LVivo Software Application is a medical software that analyzes echocardiographic ultrasound videos to automatically detect and measure the left ventricular wall and function of the heart. It helps clinicians assess cardiac function by calculating metrics like ejection fraction and myocardial strain, thus aiding in cardiac diagnosis and management.
Intended Use
The software is intended for non-invasive processing of acquired echocardiographic images to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation to assist clinicians in cardiac evaluation.
Technology
The software employs fully automated image segmentation and border detection algorithms frame-by-frame on DICOM echo clips from various vendors. It analyzes two orthogonal planes (four-chamber and two-chamber views) for global ejection fraction and strain measurement with manual editing capabilities.
Performance
The device was clinically validated in blinded studies comparing its measurements against manual biplane methods and visual estimation by physicians, demonstrating high correlations (e.g. Pearson r=0.88 for ejection fraction, r=0.85 for global longitudinal strain). The results showed high agreement in segmental wall motion and strain versus standard methods, with sensitivity/specificity values around 0.8-0.95, supporting its accuracy as a decision support tool.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/18/2016
2 months - 2
FDA Approval
7/28/2016
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