FDA clears AI-powered vascular imaging software
Nurea, a French medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its PRAEVAorta 2 software, which delivers artificial intelligence (AI)-powered measurements of vascular imaging results.
According to Nurea, approximately 20% of aortic aneurysms go undiagnosed. The company built PRAEVAorta 2—as well as its entire PRAEVAorta Suite—to help combat that trend.
PRAEVAorta 2 was designed to save physicians time when diagnosing and managing aortic aneurysm patients. The “zero click” software looks at contrast or non-contrasted CT scans and provides automated measurements that can be used to make critical treatment decisions. It can immediately measure aortic diameters or the volume of aneurysms, even differentiating the lumen from the thrombus in a way that extracts additional data.
Another key software feature is the fact that it follows the patient through their entire journey, from the initial imaging evaluation to the follow-up appointments years later.
PRAEVAorta 2 has already gained CE mark approval. This FDA clearance makes it available to vascular physicians throughout the United States.
“This milestone is the result of years of research, development and collaboration,” Florian Bernard, CEO and co-founder of Nurea, said in a statement. “FDA clearance validates our vision and allows us to bring PRAEVAorta2 to U.S. physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs and most importantly, save lives.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.