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 51…