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The FDA has signed a five-year collaborative research agreement with Dassault Systèmes Vélizy-Villacoublay, France, a world leader in 3D design software, for the development of testing paradigms for insertion, placement, and performance of pacemaker leads and other cardiovascular devices used to treat heart disease using the “Living Heart Project.”

The project uses simulated 3D personalized hearts to treat and diagnose heart diseases and for medical device development. In addition, the realistic 3D heart simulator has been moved into beta test, validated the efficacy of a device, and has surpassed 30 contributing member organizations.

Using a technology crowdsourcing model that protects the intellectual property of each member, the “Living Heart Project” is being developed with leading cardiologists, medical device companies, and academic researchers who participate in the evaluation of the simulated heart model’s use in testing medical devices, improving clinical diagnosis, and guiding pre-surgical planning.

The 30 contributing member organizations include more than 100 cardiovascular specialists from across research, industry, and medicine, who have access to the heart simulator for testing, enabling the acceleration of the program via crowdsourcing.

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