We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Dassault Systèmes, FDA Collaborate on Living Heart Project

Dassault Systèmes, FDA Collaborate on Living Heart Project

November 13, 2014

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.

Devices Regulatory Affairs Research and Development

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • NVIDIA and Medtronic to Develop Artificial Intelligence Solutions

  • FDA Approves Evkeeza for Kids With Ultra-Rare Cholesterol Disorder

  • GrayMatters Health’s Digital Therapy Device for PTSD Cleared

  • Dupixent Shows Positive Results in COPD Study

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing