Intended Use

The AI Platform is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of adult patients with suspected disease. The device is intended to be used on images from adult patients.

Technology

The device is a software as a medical device (SaMD) that imports DICOM ultrasound images, uses deep convolutional neural networks for segmentation or landmark detection, and provides tools for image viewing, landmark placement, and report generation specifically for cardiac and lung ultrasound imaging.

Performance

Performance was validated with clinical test data from multiple sites including diverse demographics. The cardiac function AI had 151 subjects, lung function AI had 125 subjects, and testing used independent datasets not involved in training. Performance metrics included intraclass correlation coefficients up to 0.95 for ejection fraction and reliability measures for lung artifact detection. Device performed consistently across subgroups and with various clinical confounders such as COPD and COVID-19.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/17/2023

    3 months
  • 2

    FDA Approval

    11/17/2023

Other devices from Exo Inc

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