Dassault Systèmes, FDA Collaborate on Living Heart Project
3D design software maker Dassault Systèmes said Wednesday that it has entered a five-year agreement with the FDA to develop testing paradigms for the insertion, placement and performance of pacemaker leads and other cardiovascular devices.
The collaboration is part of the company’s “Living Heart Project” — designed to use a realistic 3D heart simulator to test medical devices, improve clinical diagnosis and guide presurgical planning, the French company said.
The project, announced this past May, uses a technology crowdsourcing model to protect the individual intellectual property of more than 30 devicemakers, cardiologists and academic researchers who will share in the outcome.
Dassault called the agreement with FDA a significant milestone in its quest to create and use 3D personalized hearts in the treatment and diagnosis of heart disease and medical device development. The company’s first 3D heart simulator, powered by its 3DExperience simulation platform, is currently in beta testing.
Participants in the project have access to the simulator for testing and have partnered with the Medical Device Innovation Consortium to speed approval of devices developed under the collaborative effort, the company said.
MDIC President and CEO Bill Murray said the project has already been used to validate the efficacy of a novel valve assist device. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.