In 2014, the FDA began collaboration with French software company Dassault Systèmes and their simulated 3D heart model to test pacemakers and other cardiovascular devices. A recent Nextgov article discussed a new effort by the FDA to speed up the regulatory evaluation and approval process of medical devices and therapies that treat the heart. According to a request for information, the agency is now seeking a computational model of the entire human heart.
“We will need a physics-based computational model of a whole human heart, one that includes all critical functions of the heart: electrophysiology, solid mechanics, and fluid dynamics, including all relevant anatomical features (such as ventricles, atria and vessels),” the agency said in the program’s project brief. “The FDA intends to develop a generic medical device that will be virtually implanted in the whole human heart computational model.”
