EchoMD Automated Ejection Fraction Software
Bay Labs, Inc.EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.
Intended Use
The software is used to process previously acquired transthoracic cardiac ultrasound images to provide automated estimation of left ventricular ejection fraction to assist clinicians in cardiac evaluation, indicated for adult patients.
Technology
The software applies machine learning algorithms (convolutional neural networks) to biplane apical echocardiographic images from ultrasound video clips to calculate left ventricular ejection fraction. It operates as a microservice that selects relevant image clips automatically and communicates with DICOM sources and PACS systems, providing the EF measurement as a percentage along with qualitative and quantitative image quality feedback.
Performance
Performance testing included non-clinical software verification at multiple levels, retrospective validation on over 300 patient cases across various ultrasound device manufacturers, and a secondary clinical study confirming safety and effectiveness similar to the predicate LVivo EF Software. The primary endpoint used root mean square deviation (RMSD) of ejection fraction measurements, achieving 8.29% RMSD, demonstrating accurate and generalizable performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/12/2017
6 months - 2
FDA Approval
6/14/2018
Other devices from Bay Labs, Inc.
- Caption Guidance2020 • DE NOVO
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