HeartVista announced today that it received FDA 510(k) clearance for its artificial intelligence-assisted One Click MRI acquisition software.
Palo Alto, California-based HeartVista’s One Click MRI software received the FD clearance for delivery on Siemens Healthineers’ MRI scanners. The company said in a news release that its AI-assisted solutions make cardiac magnetic resonance (CMR) exams on Siemens’ MRI scanners simpler, faster and capable of delivering more consistent results.
The company said its One Click MRI software includes product-wide speed and scan accuracy enhancements, along with new real-time automated analysis of regional wall motion as part of cardiac function assessment.
Additionally, the platform includes new registration of perfusion images for easier visual defect detection, enhanced T1-mapping for cardiomyopathy analysis and dedicated septal T1-mapping for myocarditis.
HeartVista initially won FDA 510(k) clearance for the AI-assisted One Click MRI acquisition software for cardiac exams in October 2019. At the time, the company said it designed the system to prescribe the standard cardiac views with one click in as little as 10 seconds as the patient breathes freely. The system detects when images are below quality and uses volumetric parallel imaging acquisition to generate images of high quality in a fraction of the time.
“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,” HeartVista CEO Itamar Kandel said in the release. “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.”