FDA clears AI-powered echocardiography software
DESKi, a French medtech company focused on expanding the use of artificial intelligence (AI) in healthcare, has received U.S. Food and Drug Administration (FDA) clearance for its AI-enabled HeartFocus software.
HeartFocus was designed to help all healthcare professionals, even those with no prior training, perform high-quality echocardiograms using cart-based, compact or handheld imaging equipment. Its user interface guides the user through the exam, ensuring the final echo will include all the information needed for it to be properly evaluated.
“Heart disease is the number one killer worldwide, and echocardiography is the first step to receiving a diagnosis and proper treatment,” Bertrand Moal, MD, PhD, CEO of DESKi, said in a prepared statement. “However, there is a critical shortage of cardiologists and expert sonographers to meet demand. HeartFocus bridges that gap, empowering any healthcare provider, anywhere, to capture cardiac images with precision and confidence. This clearance affirms our technology and accelerates our ability to bring earlier diagnosis and life-saving care to all who need it, including rural and underserved communities.”
“HeartFocus is opening the door to a new era in cardiac imaging,” added Stéphane Lafitte, MD, a professor of cardiology and echocardiography specialist at CHU de Bordeaux. “We’ve proven that AI can empower novices to reliably perform echocardiograms, a breakthrough that could reshape how we diagnose and treat heart disease. It’s an exciting advancement for the field of cardiology, with the potential to extend high-quality care to more patients globally than ever before.”
Recent data on the technology’s performance
Researchers presented new data on HeartFocus at ACC.25, the annual meeting of the American College of Cardiology. Overall, exploring data from more than 200 patients, exams performed by novices using HeartFocus were comparable to those performed by expert sonographers and cardiologists.
“I could not be more proud of the trial's incredible outcomes, and excited by the prospects it brings for heart disease detection, prevention and management,” Moal said when the data were announced.
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.