HeartVista has received US Food and Drug Administration (FDA) 510(k) clearance to deliver its AI-assisted One Click magnetic resonance imaging (MRI) acquisition software on Siemens Healthineers MRI scanners.
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, HeartVista said in a press release. With HeartVista’s AI-assisted solutions, CMR exams on Siemens’ MRI scanners are simpler, significantly faster, and achieve more consistent results, the company added.
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, the company’s press release states.
“We are 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, 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.”