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

Technology

The LVivo platform uses automated analysis of echocardiographic examinations through DICOM ultrasound movie files. It evaluates global and segmental left ventricle (LV) function from several apical views (4CH, 2CH, 3CH) and parasternal views (SAX and PLAX). The platform includes several modules for LV, right ventricular function, and bladder volume measurement, with automated frame selection, manual adjustment capability, and presentation of cardiac function results. The PLAX module extends the system to provide LV size and wall thickness measurements for rapid point-of-care evaluation.

Performance

Performance evaluation included clinical validation on 121 patients undergoing transthoracic echocardiography, demonstrating strong correlation to manual measurements (r=0.79), with sensitivity and specificity of 85%. Additional validation on 40 patients for the PLAX module showed 90% automatic analysis rate with acceptable bias and limits of agreement for calculated parameters. The device meets acceptance criteria and effectively analyzes cardiac function from ultrasound.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/28/2024

    7 months
  • 2

    FDA Approval

    10/4/2024

Other devices from DiA Imaging Analysis Ltd.

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