Key Highlights
- AISAP CARDIO receives FDA 510(k) clearance for AI-powered cardiac diagnostics.
- Integrates 4 CADx modules and 8 key measurements into a comprehensive software platform.
- Enables accurate diagnosis of 90% of common cardiac issues within minutes at the bedside.
- Telemedicine and cloud-based solution, compatible with existing EHR/EMR systems.
Source: Business Wire
Notable Quotes
- “AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound.” — Smadar Kort, MD, System Director, Non Invasive Cardiac Imaging at Stony Brook Medicine
- “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.” — Ehud Raanani, MD, Co-founder at AISAP
SoHC's Take
AISAP’s CARDIO platform represents a significant advancement in point-of-care diagnostics by bringing AI-driven, comprehensive cardiac ultrasound directly to the bedside. The FDA’s 510(k) clearance is a pivotal achievement, underscoring the platform’s clinical validation and its potential to streamline diagnostic processes across healthcare settings. By enabling non-cardiologist clinicians to achieve diagnostic accuracy on par with expert cardiologists, CARDIO could significantly enhance early detection and treatment of cardiac conditions, ultimately leading to better patient outcomes and cost savings for healthcare systems. This innovation is poised to transform how cardiac care is delivered, especially in emergency and remote settings.
