HeartFocus, an artificial intelligence (AI)-powered cardiac imaging software developed by DESKi, has received clearance from the US Food and Drug Administration (FDA), allowing its use by non-specialist healthcare providers to conduct diagnostic-grade heart scans.
The approval also covers DESKi’s Predetermined Change Control Plan (PCCP), enabling integration with additional ultrasound platforms without requiring separate FDA submissions.
The dual clearance is expected to accelerate HeartFocus’s rollout across healthcare systems and extend access to early cardiac diagnostics in underserved areas.
Designed to reduce dependency on trained cardiologists and sonographers, HeartFocus allows any trained healthcare professional to perform echocardiography using a compatible device after only a few hours of instruction. This could address growing gaps in diagnostic capacity amid rising cardiovascular disease cases and shortages in specialist personnel.
DESKi CEO Bertrand Moal said: “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.”
Created in 2023 by Bertrand and Olivier Moal, HeartFocus was developed in response to strained cardiac care infrastructure. The platform uses proprietary AI algorithms trained on more than 10 million data points, designed to guide users in capturing high-quality cardiac images even without prior imaging experience.
Its performance was validated through a multi-centre, blinded clinical trial led by Northwell Health in the US and the University Hospital of Bordeaux (CHU) in France.
According to trial data, 100% of cardiac scans performed by novice users with HeartFocus met diagnostic criteria for all primary endpoints. Results were comparable to those achieved by expert sonographers.
Northwell global and international health senior vice president Varinder Singh said: “The clinical trial results and subsequent FDA clearance mark a major step forward in making echocardiography more accessible in the community.
“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.”
