HeartVista Gets FDA’s 510(k) Clearance for One Click MRI

HeartVista has received the FDA’s 510(k) clearance for its artificial intelligence-assisted One Click MRI acquisition software, which runs on Siemens Healthineers MRI scanners.

The software includes productwide speed and scan accuracy enhancements, according to Palo Alto, Calif.-based HeartVista.

One Click MRI also features real-time automated analysis of regional wall motion as part of cardiac function assessment, registration of perfusion images for easier visual defect detection, enhanced T1-mapping for cardiomyopathy analysis and dedicated septal T1-mapping for myocarditis.

“On the basis of the diagnostic accuracy of cardiac MRI for coronary artery disease and myocarditis, the test is now recommended as a Class I recommendation for the evaluation of chest pain,” said HeartVista Chief Medical Officer Bob Hu.