AISAP, a medical technology company developing AI-powered Point-of-Care Assisted Diagnosis solutions to transform medical ultrasound, has announced that the FDA has granted 510(k) clearance for its ‘first-of-a-kind’, AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software platform.

The cloud-based platform combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a single cardiac ultrasound software package that automatically generates analyses, interpretations and reports. CARDIO empowers clinicians with basic scanning skills to accurately diagnose up to 90 percent of the most common cardiac structural and functional parameters right at the bedside within minutes.

“AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound,” said Smadar Kort, MD, system director of Non Invasive Cardiac Imaging, Stony Brook Medicine, and past governor of the American College of Cardiology. “We know that structural heart disease and heart failure are the leading causes of hospitalisation and morbidity in the U.S. Enabling a wide variety of qualified physicians to quickly and accurately diagnose these conditions at the bedside could lead to earlier detection and treatment, and better patient outcomes, as well as greater efficiencies and cost savings to health systems, while ultimately saving countless lives.”