Bordeaux, France— The U.S. Food and Drug Administration (FDA) has granted clearance to HeartFocus, an artificial intelligence-powered cardiac imaging software developed by French medtech company DESKi. The approval marks a significant step toward democratizing heart diagnostics by allowing healthcare professionals—with minimal training—to conduct clinical-grade echocardiograms using compatible devices.
HeartFocus leverages AI to guide users through the process of capturing diagnostic-quality heart scans, enabling even novice providers to produce reliable results after just a few hours of training. DESKi said the software has the potential to address growing demand for cardiac imaging amid a global shortage of cardiologists and trained sonographers.
“Heart disease remains the leading cause of death globally, and early detection is critical,” said Dr. Bertrand Moal, CEO of DESKi. “This FDA 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.”
In addition to clearing the software itself, the FDA also approved DESKi’s Predetermined Change Control Plan (PCCP), paving the way for future integration of HeartFocus with a broader range of ultrasound systems—potentially accelerating its reach.
The clearance follows a pivotal international clinical trial conducted in collaboration with Northwell Health in the U.S. and the University Hospital of Bordeaux (CHU) in France. According to DESKi, the blind review showed that 100% of the scans performed by novices using HeartFocus met all diagnostic standards, with results comparable to those from expert sonographers.
Dr. Varinder P. Singh, Senior Vice President of Global and International Health at Northwell, called the development “a major step forward in making echocardiography more accessible in the community.” He added, “HeartFocus will help patients get diagnosed sooner and move more quickly toward the treatment they need.”
“HeartFocus is opening the door to a new era in cardiac imaging,” said Prof. Stéphane Lafitte, a cardiologist 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.”
With FDA clearance secured, DESKi aims to expand HeartFocus’ availability across the U.S. and globally, targeting areas where cardiac expertise is scarce.
