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HeartVista Receives FDA 510(k) Clearance to Deliver One Click MRI™ on Siemens Healthineers MRI Scanners

New AHA and ACC Guidelines, Making Cardiac MRI a Class I Recommendation for Chest Pain, Will Increase CMR Use to Widely Impact the Practice of Cardiology

HeartVista, a pioneer in AI-assisted MRI solutions, today announced it has received 510(k) Clearance from the U.S. Food and Drug Administration, to deliver its AI-assisted One Click MRI™ acquisition software on Siemens Healthineers MRI scanners.

Despite many advantages, the use of cardiac MRI, also known as cardiac magnetic resonance (CMR), has been largely limited due to a lack of trained technologists, high cost, long scan time and difficulty of use. With HeartVista’s AI-assisted solutions, CMR exams on Siemens’ MRI scanners are simpler, significantly faster, and achieve more consistent results.

Siemens is a global leader in Magnetic Resonance (MR), and clinical decision-making. One Click MRI™ clearance on Siemens Healthineers MRI scanners advances HeartVista’s mission of improving and increasing patient access to real-time MRI imaging, to enable better treatment decisions for physicians.

Beyond compatibility with Siemens Healthineers MRI scanners, the newly FDA-cleared One Click MRI™ software includes product-wide speed and scan accuracy enhancements, as well new real-time automated analysis of regional wall motion as part of cardiac function assessment, new registration of perfusion images for easier visual defect detection, enhanced T1-mapping for cardiomyopathy analysis, and dedicated septal T1-mapping for myocarditis.

“We’re excited to receive FDA 510(k) Clearance for One-Click MRI™ with Siemens scanners, which positions us as a multi-vendor platform for global CMR deployment. This groundbreaking achievement was a result of our hardworking R&D team’s efforts. The team dedicated over 5,000 hours to the clearance process during a pandemic, and evaluated our software by scanning a broad array of patients and volunteers on multiple MRI machines across three countries,” said Itamar Kandel, CEO of HeartVista. “By expanding our cardiac MRI compatibility to include Siemens Healthineers’ scanners, some of the world’s most popular MRI machines, we have taken a major leap forward to enable cardiac MRI access for all.”

The American Heart Association (AHA), the American College of Cardiology (ACC), and other groups issued new guidelines, making cardiac magnetic resonance (CMR) a Class I recommendation as a front-line testing strategy for the diagnosis of chest pain.

“Chest pain is one of the most important and most common symptoms our patients complain about. 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 Bob S. Hu, M.D., HeartVista’s Chief Medical Officer. “This recent FDA 510(k) Clearance will enable increased access to HeartVista’s AI-assisted One Click MRI™ acquisition software, enabling physicians to make better treatment decisions for patients.”

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