DESKi today announced FDA clearance of HeartFocus, its AI-enabled heart exam software.
Bordeaux, France–based DESKi says it only takes a few hours of training for any healthcare professional, including novices, to perform clinical-quality heart scans from any compatible device using HeartFocus.
The FDA also signed off on DESKi’s Predetermined Change Control Plan (PCCP) for HeartFocus’ growth opportunities. The PCCP enables faster collaboration with other ultrasound systems so the technology can reach more patients sooner.
“Heart disease is the number one killer worldwide, and echocardiography is the first step to receiving a diagnosis and proper treatment. 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,” DESKi CEO Dr. Bertrand Moal said in a news release.
“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.”
DESKi validated HeartFocus’ efficacy in a landmark international clinical trial conducted in partnership with Northwell Health in the United States and the University Hospital of Bordeaux (CHU) in France. In a blind review, 100% of novice-conducted scans using HeartFocus met diagnostic standards for all primary endpoints and were comparable to those completed by expert sonographers, according to DESKi.
“The clinical trial results and subsequent FDA clearance mark a major step forward in making echocardiography more accessible in the community,” said Dr. Varinder P. Singh, SVP, Global and International Health, Northwell. “Proving that it can successfully guide any healthcare professional to capture high-quality heart scans, HeartFocus will help patients get diagnosed sooner and move more quickly toward the treatment they need.”
Stéphane Lafitte, Professor of Cardiology at CHU de Bordeaux, said HeartFocus will open the door to a new era in cardiac imaging. “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.”
