Bay Labs has received 510(k) clearance from U.S. FDA for use of its EchoMD AutoEF software product to provide fully automated clip selection and calculation of left ventricular ejection fraction (EF), the San Francisco–based company said today.
The EF is the percentage of blood leaving a heart each time it contracts. Bay Labs in its news release desribed it as the single most-used measurement of cardiac function when it comes to clinical decisionmaking. The EchoMD AutoEF algorithms do away with the need to manually select views, choose the best clips, and manipulate them for quantification — time-consuming and highly variable process while taking an EF measurement.
“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 Dr. Neil J. Weissman, 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,” Weissman said.
The FDA clearance news comes about half a year after Bay Labs announced a $5.5 million money raise in a Series A round.