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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. In addition, it has the ability to provide Quality Score feedback.

Technology

The LVivo platform supports automated analysis of echocardiographic examinations using DICOM ultrasound movies for global and segmental evaluation of the left ventricle function and right ventricular function. It uses machine learning algorithms to analyze multiple apical and parasternal views and provides automated ejection fraction, strain, and wall motion evaluation. It includes modules for offline analysis and real-time quality feedback during image acquisition.

Performance

Performance evaluation included a clinical validation using 170 echocardiographic exams from multiple medical centers with both US and international data. The software demonstrated sensitivity and specificity around 82%, accuracy of 82%, and high agreement with expert assessments for wall motion scoring index (WMSI), showing ICC of 0.85 with ground truth from experts. Additional testing on an external dataset of 101 patients confirmed these results.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/16/2024

    3 months
  • 2

    FDA Approval

    3/17/2025

Other devices from DiA Imaging Analysis Ltd.

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