Imaging provider gains FDA clearance, CE mark approval for AI-powered right ventricle assessments
DiA Imaging Analysis has gained FDA clearance and CE mark approval for its AI-powered solution designed to automatically assess right ventricle dysfunction.
LVivo RV uses AI technology and ultrasound imaging to diagnose and monitor various right heart conditions. Considering data that has found associations between COVID-19 mortality and right ventricle heart failure, DiA has said the algorithm could also be used as a tool to provide care during the ongoing pandemic.
“Physicians now face a host of new challenges and restrictions on the frontlines that underscores the critical role of ultrasound and value of having access to AI-powered solutions,” Hila Goldman-Aslan, DiA’s CEO and co-founder, said in a prepared statement. “With today’s FDA and CE approvals, DiA takes a big step toward strengthening our AI offerings for cardiac ultrasound while realizing our vision of making ultrasound analysis smarter and more accessible across a broader range of healthcare segments.”
“The right ventricle has always been very difficult to evaluate due to its unique structure and location,” added Anthony M. Demaria, MD, a cardiologist at the University of California, San Diego Medical Center who has experiencing using LVivo RV. “This is further compounded by the complexity of the analysis itself, which relies on a combination of manual calculations and visual user input. LVivo RV is a welcome and very useful addition to clinicians’ toolbox for more quickly and effectively monitoring the right ventricle.”
The company has also gained FDA clearance and CE mark approval for another solution, LVivo Bladder, which was designed to provide automatic bladder volume measurements.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.