Intended Use

Assist medical professionals in acquisition of cardiac ultrasound images (2D transthoracic echocardiography) to acquire standard 2D echocardiographic views in adult patients.

Technology

Uses AI deep learning algorithms to provide real-time quality feedback and prescriptive guidance for probe positioning, along with auto-capture and save-best-clip features, integrated with Terason uSmart 3200t Plus ultrasound hardware.

Performance

Clinical and non-clinical testing demonstrated that Caption Guidance enables non-specialists to acquire diagnostic quality echocardiographic images comparable to sonographers, with high rates of diagnostic image quality across multiple standard cardiac views and strong agreement on clinical assessments by cardiologists.

Device Timeline

  • 1

    Submission

    8/27/2019

    5 months
  • 2

    FDA Approval

    2/7/2020

Other devices from Bay Labs, Inc.

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