FDA Clears HeartVista’s AI-Assisted Cardiac MRI Software

The FDA granted HeartVista 510(k) clearance for its One Click AI-assisted magnetic resonance imaging acquisition software for use in cardiac MRIs.

The software provides standard cardiac views in just ten seconds while the patient breathes freely, taking the complexity and long scan times out of cardiac MRIs.

The software also flags when the image quality is subpar and prompts the operator to reacquire the images if they wish.