DESKi Secures FDA Clearance for AI Heart Imaging Software

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DESKi has received FDA clearance for HeartFocus, its AI-powered heart exam software that enables any healthcare provider—even novices—to perform diagnostic-quality echocardiograms with minimal training.

The software works on compatible devices and was validated through an international clinical trial. All novice scans met expert-level standards. The FDA also approved a Predetermined Change Control Plan (PCCP), accelerating integration with other ultrasound systems.

HeartFocus aims to address the global shortage of cardiologists by making high-quality cardiac imaging more accessible, especially in underserved communities.

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