Cardiac Guidance
Caption Health, Inc.Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.
Intended Use
Assist medical professionals in acquisition of cardiac ultrasound images using two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, acquiring specific standard cardiac views as an accessory to diagnostic ultrasound systems.
Technology
The Cardiac Guidance software is a radiological computer-assisted acquisition guidance system providing real-time AI-powered feedback during echocardiography. Key features include a Quality Meter for clip diagnostic quality feedback, Prescriptive Guidance directing probe manipulation, Auto-Capture of diagnostic clips, and Save Best Clip functionality. It emulates skilled sonographers for acquisition of standard 2D echocardiographic views.
Performance
The device performance was evaluated through software verification and validation tests, including new tests to support modifications. Testing involved clinical endpoints, usability, human factors, and comparison to the predicate. Validation datasets represent the intended population, ensuring safety and effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
3 months - 2
FDA Approval
1/15/2025
Other devices from Caption Health, Inc.
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- Caption Guidance2020 • 510K
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