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The FDA Wants a Virtual Heart to Test Medical Devices

The FDA is seeking computational software that models the human heart to test medical devices and therapies.

Digital Heart / Image: Shutterstock
Digital Heart / Image: Shutterstock

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.”

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