FDA Clears HeartFocus, AI-Powered Cardiac Imaging Software
DESKi has announced that its AI-powered heart imaging software, HeartFocus, has received FDA clearance. Designed to simplify cardiac exams, HeartFocus enables any healthcare professional—even those with minimal experience—to perform clinical-quality heart scans using compatible devices, after only a few hours of training.
DESKi, a health tech innovator, announced today that its AI-powered cardiac imaging software, HeartFocus, has received FDA clearance along with approval of its Predetermined Change Control Plan (PCCP). This milestone paves the way for accelerated growth and integration of the technology with additional ultrasound systems, dramatically increasing its potential to reach patients in need of early cardiac diagnosis.
HeartFocus is designed to transform how echocardiography—the gold standard for diagnosing heart disease—is performed and accessed. With just a few hours of training, healthcare professionals of any background, including those with little to no imaging experience, can use the software to perform clinical-quality heart scans from any compatible ultrasound device. By drastically reducing the learning curve and dependency on specialists, HeartFocus addresses a critical shortage of cardiologists and expert sonographers worldwide.
“Heart disease is the leading cause of death globally, and echocardiography is the essential first step toward diagnosis and treatment,” said Dr. Bertrand Moal, CEO of DESKi and co-creator of HeartFocus. “But the demand far outpaces the number of trained professionals. HeartFocus bridges that gap by empowering any healthcare provider, anywhere, to capture accurate cardiac images with precision and confidence.”
With the FDA’s approval of the PCCP, DESKi now has a streamlined pathway to expand HeartFocus’s functionality and integrate it with a wider range of ultrasound systems—ensuring faster deployment and access to care, especially in underserved or remote communities.
“This clearance validates our technology and accelerates our mission to bring earlier diagnosis and life-saving care to patients who might otherwise face long delays or lack access entirely,” added Moal. “We’re particularly excited about the potential to serve rural populations and resource-limited health systems where cardiac expertise is scarce.”
Validated by Global Clinical Evidence
The safety and effectiveness of HeartFocus were confirmed through a landmark international clinical trial conducted in partnership with Northwell Health in the United States and CHU Bordeaux (University Hospital of Bordeaux) in France. The study tested HeartFocus in real-world clinical environments, evaluating its ability to guide novice healthcare professionals in performing echocardiograms.
The results were striking: in a blind review, 100% of the scans conducted by novices met diagnostic standards for all primary endpoints and were deemed comparable in quality to those captured by experienced sonographers.
“This is a major step forward for community-based cardiac care,” said Dr. Varinder P. Singh, SVP of Global and International Health at Northwell Health. “The ability to guide any healthcare provider to generate diagnostic-quality heart scans means patients can be diagnosed earlier and move more quickly toward the treatment they need.”
Cardiologists across the globe are taking note. Stéphane Lafitte, Professor of Cardiology at CHU de Bordeaux, called HeartFocus a game-changer. “We’ve demonstrated that artificial intelligence can empower non-specialists to reliably conduct heart exams. This has profound implications for how we diagnose and manage heart disease globally. It’s an exciting advancement that will extend high-quality cardiac care to many more patients.”
Behind the Technology
HeartFocus was launched in 2023 by French brothers Bertrand and Olivier Moal. Bertrand, a medical doctor with a PhD in biomechanical engineering, and Olivier, an engineer educated at EPFL and UC Berkeley, were inspired to tackle the growing burden of cardiovascular disease, particularly in overstrained healthcare systems.
Their solution: a revolutionary platform powered by proprietary AI algorithms trained on more than 10 million clinical data points, designed to simplify and democratize access to cardiac imaging. With a shared mission rooted in the belief that “No heart can wait™,” the Moal brothers created HeartFocus as a scalable solution to facilitate early detection and improve patient outcomes around the world.
In 2024, HeartFocus was recognized with the France 2030 Award from the French Ministry of Health for its groundbreaking approach to personalized cardiac care. The technology is also integrated with major app platforms and SDK providers, including Butterfly Network in the U.S., enabling flexible, global deployment across diverse care settings.
