In a blind review, scans performed by novices using the software met diagnostic standards and matched expert-level quality.
DESKi announced US Food and Drug Administration (FDA) clearance for HeartFocus, its artificial intelligence (AI)-enabled heart exam software that is designed to enable any healthcare professional, including novices, to perform clinical-quality heart scans from any compatible device after just a few hours of training.
The FDA also approved DESKi’s Predetermined Change Control Plan for HeartFocus’ growth opportunities. This clears the way for 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,” says Bertrand Moal, PhD, MD, CEO of DESKi, in a 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.”
Clinical Trial
The efficacy of HeartFocus was validated in an 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.
“The clinical trial results and subsequent FDA clearance mark a major step forward in making echocardiography more accessible in the community,” says Varinder P. Singh, MD, senior vice president of global and international health at Northwell Health, in a release. “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.”
HeartFocus is the latest offering by DESKi, a provider of AI products developed in conjunction with medical practitioners and researchers.
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