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FDA Seeks Virtual Heart to Test Medical Devices

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human heart, illustration

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The U.S. Food and Drug Administration is working with French software company Dassault Systemes to develop a virtual model of the human heart for evaluating new medical devices and treatments. "The FDA intends to develop a generic medical device that will be virtually implanted in the whole human heart computational model," the project brief says. Researchers will design, build, and physically and virtually test this device on virtual populations and devise new techniques for integrating digital evidence from simulations with physical evidence from actual patients.

The FDA's ultimate goal is to apply digital evidence and computer models to accelerate regulatory evaluation and approval, ahead of the market rollout of new medical solutions.

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