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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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Discover the right packaging solutions for life sciences in Philadelphia
Explore innovative packaging and supply chain solutions for the life sciences at the largest PACK EXPO East in history, March 18–20. Get ideas from 400+ top exhibitors and connect with colleagues and industry experts—all in one convenient location!
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Discover the right packaging solutions for life sciences in Philadelphia