The FDA Wants a Virtual Heart to Test Medical Devices

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.”