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FDA Clears CT-Based AI Software for Detecting Enlarged Heart Chambers
The AI-enabled AutoChamber software also garnered the FDA’s breakthrough device designation for opportunistic detection of enlarged heart chambers on non-contrast CT scans.
The Food and Drug Administration (FDA) has granted its breakthrough device designation and 510(k) clearance for AutoChamber™, an artificial intelligence (AI)-enabled software for computed tomography (CT) that may facilitate early detection of enlarged heart chambers.
Leveraging deep learning-based AI, the AutoChamber software calculates the volume of cardiac chambers and left ventricular wall mass in 15 to 20 seconds, according to HeartLung Technologies, the manufacturer of AutoChamber.
The newly FDA-cleared AutoChamber software leverages deep learning-based AI to calculate the volume of cardiac chambers and left ventricular wall mass in 15 to 20 seconds, according to HeartLung Technologies, the developer of the software. (Images courtesy of HeartLung Technologies.)
The company said AutoChamber, which can be utilized for heart CT and coronary CT angiography (CCTA) scans as well as chest CT for lung cancer screening, may help identify patients who have higher risks for atrial fibrillation, stroke, and heart failure.
“I feel strongly about the opportunity AutoChamber may have to evaluate cardiovascular risk for the millions of persons getting chest CT scans worldwide, in particular for lung cancer screening and other non-cardiac reasons,” noted Nathan Wong, M.D., a professor of director of the Heart Disease Prevention Program within the Division of Cardiology at the University of California, Irvine in Irvine, Calif. “The potential is for identifying those at increased risk who could benefit from earlier intervention to improve outcomes.”
FDA Clears AI-Powered Ultrasound Software for Cardiac Amyloidosis Detection
November 20th 2024The AI-enabled EchoGo® Amyloidosis software for echocardiography has reportedly demonstrated an 84.5 percent sensitivity rate for diagnosing cardiac amyloidosis in heart failure patients 65 years of age and older.
