Medical Devices

Electromagnetic Modeling

Contact

Kyoko Fujimoto, Ph.D.

Summary

This group supports the agency's regulatory and guidance role by advancing our knowledge on the complex interactions between electromagnetic (EM) fields and the human body. The research combines anatomically detailed computational models and experimental measurements applied to several areas of clinical significance, including the: 1) analysis of radiofrequency (RF)-induced energy deposition in patients during magnetic resonance imaging (MRI); 2) heating in patients with implanted passive medical devices during MRI scans; 3) analysis of the safety and effectiveness of active implantable devices such as deep brain stimulators and pacemakers; 4) RF safety of human subjects during interventional MRI; and 5) analysis of patient safety with respect to gradient-induced heating and unintended nerve stimulation undergoing MRI, 6) evaluation of effectiveness of wireless technology which can be implanted in patients. These projects are conducted with active collaborations between several researchers, within the FDA and worldwide, at leading academic research institutes and industry organizations.

Virtual Family

The Virtual Family: Four highly detailed, anatomically correct whole-body computer models in CAD (Computer Aided Design) format of an adult male, an adult female, and two children.


MIDA head model

Surface view of the MIDA model, a Multimodal Imaging-based Detailed Anatomical computer model of the human head and neck. The MIDA model offers detailed representation of 153 different structures and can be used for modeling and numerical analysis of medical devices in, on, or near the head.


3D specific absorption rate (SAR) maps of the blood vessels for the hip bone imaging landmark during 1.5 T MRI.

There is a direct impact on the regulatory mission of the Agency, as the tools developed by our research are extensively used by industry in pre-market evaluation for the safety and effectiveness of their medical devices. The research is funded by both internal (Office of Women's Health) and external (CRADA) support. Additionally, we are currently leading the Medical Device Innovation Consortium (MDIC) working group on Computational Modeling and Simulations – RF heating in MRI.

Current funding sources

FDA Office of Women's Health
Cooperative Research and Development Agreement (CRADA) – Imricor Inc.

Personnel

FDA Staff:
Kyoko Fujimoto, Ph.D.
Howard Bassen
Joshua Guag
Wolfgang Kainz, Ph.D.
Sunder Rajan, Ph.D.
 

External collaborators

Resource facilities

Hardware

Software

  • Electromagnetic and thermal solvers:
    • Sim4Life disclaimer icon (ZMT Zurich MedTech AG, Zurich, Switzerland),
    • XFDTD disclaimer icon (Remcom Inc., State College, PA)
    • HFSSdisclaimer icon (ANSYS Inc., Canonsburg, PA

Public domain software

Virtual Family Website
MIDA Website

Relevant standards & guidance

Reporting of Computational Modeling Studies in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

Selected peer reviewed publications

Page Last Updated: 04/05/2019
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