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 Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation
June 18th 2025The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.
Multinational Study Reaffirms Value of Adjunctive AI for Prostate MRI
June 16th 2025The use of adjunctive AI in biparametric prostate MRI exams led to 3.3 percent and 3.4 percent increases in the AUC and specificity, respectively, for clinically significant prostate cancer (csPCa) in a 360-person cohort drawn from 53 facilities.