Intended Use

DiA’s 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.

Technology

The LVivo system uses automated analysis of DICOM ultrasound movie clips from two orthogonal planes (4-chamber and 2-chamber) for fully automated left ventricular function analyses, strain measurements, right ventricular evaluation using a combination of image processing and deep learning neural networks, and bladder volume assessment by segmenting bladder contours using machine learning and active contour methods.

Performance

Clinical validation studies showed high correlation of automated measurements with manual expert measurements for various parameters including FAC, TAPSE, strain, and bladder volume, demonstrating strong agreement and reliability comparable to conventional methods.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/30/2020

    4 months
  • 2

    FDA Approval

    6/23/2020

Other devices from DiA Imaging Analysis Ltd

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