Startup Gets FDA Approval For Cardiac Ultrasound Software 

Medtech startup AISAP has received approval from the US Food and Drug Administration (FDA) for its unique CARDIO point-of-care ultrasound (POCUS) platform, which automatically generates analyses, interpretations and reports on a patient suffering from heart disease. 

The software platform allows clinicians to accurately diagnose up to 90 percent of the most common cardiac parameters within minutes, both early in the evaluation process and at any stage necessary during the course of treatment.

The platform was trained on hundreds of thousands of studies and its novel algorithms were validated in wide-ranging clinical trials, including at Mass General Brigham, the leading US institution for hospital-based research, and the Mayo Clinic, the top ranked medical center in the United States.

“AISAP CARDIO was developed by top-notch technologists and cardiologists to close critical gaps in patient care. Our ‘anywhere, anytime AI’ approach is aimed at transforming healthcare by bringing cutting-edge diagnostic tools to the point of care,” said AISAP CEO Adiel Am-Shalom. 

“This milestone makes AISAP the first company in the world to secure FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS,” said AISAP co-founder Ehud Raanani MD, the director of the Leviev Cardiovascular and Thoracic Center at Sheba Medical Center. 

“It marks a big step in our goal of delivering point-of-care assisted diagnosis, or POCAD, with unparalleled scalability and accessibility – from the largest academic centers to the most remote rural locations,” he said.