FDA Clearance for Bay Labs’ EchoMD AutoEF Software for Fully Automated AI Echocardiogram Analysis

The EchoMD AutoEF Algorithms Eliminate The Need To Manually Select Views, Choose The Best Clips, And Manipulate Them For Quantification, An Often Time-Consuming And Highly Variable Process

Bay Labs, a medical technology company at the forefront of applying artificial intelligence (AI) to cardiovascular imaging, today announced its EchoMD AutoEF software product received 510(k) clearance from the US Food and Drug Administration (FDA) for the fully automated clip selection and calculation of left ventricular ejection fraction (EF). EF is the single most widely used metric of cardiac function and used as the basis for many clinical decisions. The EchoMD AutoEF algorithms eliminate the need to manually select views, choose the best clips, and manipulate them for quantification, an often time-consuming and highly variable process.

“Left ventricular ejection fraction has been a mainstay of echocardiography for the last 50 years. Bay Labs’ use of artificial intelligence for image selection and automated EF measurement will allow clinicians across a wide range of experience to obtain accurate evaluation of ventricular function and aid in interpretation of the echocardiograms with greater efficiency,” said Neil J. Weissman, MD, FACC, FASE, chief scientific officer for MedStar Health, president of MedStar Health Research Institute and a professor of medicine at Georgetown University School of Medicine. “This will ultimately result in more effective care for our patients.”

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Unlike current technologies, EchoMD AutoEF automatically reviews all the relevant digital video clips of cardiac cycles from a patient’s echocardiography study, rates them according to image quality, and selects the best ones to calculate the EF, the leading measurement of cardiac function from echocardiograms. The EchoMD AutoEF software algorithm “learned” clip selection and EF calculation after being trained on a carefully curated dataset of over 4,000,000 images, representing 9,000 patients. Through partnerships with leading cardiology clinical institutions, and unique expertise in the processing of large diagnostic imaging datasets, Bay Labs has created a massive archive of carefully curated studies optimized for deep learning algorithm development.

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EchoMD AutoEF software can be integrated into any DICOM PACS medical imaging environment and provides cardiologists with results as a seamless part of routine diagnostic workflow. Bay Labs will make EchoMD AutoEF available to support fast, efficient and accurate AI-assisted echocardiogram analysis to ensure the highest quality care for patients.

“At Bay Labs, our hope is that EchoMD AutoEF will assist cardiologists in their decision making and enhance the care they provide to their patients,” said Charles Cadieu, co-founder and CEO of Bay Labs. “We look forward to continuing to develop unique deep learning technologies that enable expanded access to high-quality echocardiography image acquisition and interpretation, with the goal to improve disease management and patient outcomes through earlier detection and monitoring.”

Bay Labs is a San Francisco-based privately held company focused on increasing quality, value and access to medical imaging by combining deep learning and ultrasound. Founded in 2013, Bay Labs applies artificial intelligence to cardiovascular imaging, and its deep learning technology is designed to help medical professionals of all skill levels perform and interpret high-quality echocardiography to ultimately benefit their patients. There are over 10 million echoes performed annually in the United States, and according to the Centers for Disease Control, over 600,000 people in the U.S. die from cardiovascular disease each year making it the cause of one in four deaths. Bay Labs is funded by Khosla Ventures, Data Collective, and other leading venture capital firms

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