Point-of-care AI ultrasound system for diagnosis of cardiac pathologies nets FDA clearance
Click Here to Manage Email Alerts
Key takeaways:
- The FDA cleared a point-of-care AI ultrasound tool for the diagnosis of multiple cardiac pathologies.
- The platform was trained using millions of echocardiograms and validated at several large health systems.
AISAP announced the FDA granted 510(k) clearance for its first-in-class, AI-powered point-of-care ultrasound software platform for the measurement of several cardiac pathologies.
The cloud-based platform (CARDIO, AISAP) is indicated for the diagnostic assessment and measurement of mitral, tricuspid and aortic valve regurgitation and stenosis; left ventricular ejection fraction; right and LV dimensions; RV fractional area change; atrial areas; ascending aorta diameter; and inferior vena cava diameter, according to a company release.
The platform is designed to generate validated assessments in minutes at point-of-care and seamlessly integrate into existing electronic health record and picture archiving and communication systems, according to the release.
The platform was trained using more than 24 million echocardiograms and was validated in clinical trials at Mass General Brigham, Thomas Jefferson University Hospital, Mayo Clinic, Inova Fairfax Medical Campus, Crozer-Chester Medical Center and Stony Brook University Hospital.
The platform demonstrated a 93% sensitivity and 93% specificity of the accurate diagnosis of aortic stenosis and regurgitation and mitral and tricuspid regurgitation, according to the release.
“AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound,” Smadar Kort, MD, system director of noninvasive cardiac imaging at Stony Brook Medicine and past governor of the American College of Cardiology, said in the release. “We know that structural heart disease and heart failure are the leading causes of hospitalization 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.”
Collapse
Click Here to Manage Email Alerts