Libby Echo:Prio
Dyad Medical, IncLibby Echo:Prio is a software tool that processes DICOM-compliant cardiac ultrasound images to provide automated measurements and analysis of cardiac function, such as ejection fraction and heart rate. It supports cardiologists and sonographers by automating view classification, border segmentation, and generating quantification reports, thus aiding clinical decision-making in cardiac care.
Intended Use
Libby Echo:Prio is software that processes previously acquired DICOM-compliant cardiac ultrasound images to make measurements that provide automated estimation of several cardiac measurements, supporting qualified cardiologists, sonographers, or other licensed healthcare practitioners for clinical decision-making in adult patients.
Technology
Echo:Prio uses AI machine learning-based view classification and border segmentation to automatically identify cardiac ultrasound views and segment left ventricle chamber, left atrium, and myocardium. It provides 2D and cine loop review, secondary captures review, quantitative measurements including ejection fraction, heart rate estimates, and generates a summary report.
Performance
Performance testing on diverse clinical datasets showed view classification accuracy of 97% with F1 score >96.6%, sensitivity 96.8%, specificity 98.5%. Heart rate estimates closely matched 12-lead ECG ground truth with slope 0.98. Ejection fraction predictions had good correlation to expert annotations (slope 0.79, 95% CI 0.52-0.98), within expected inter-observer variability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/1/2022
3 months - 2
FDA Approval
7/20/2022
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