Medical Devices

Electromagnetic Modeling

 

Contact

Leonardo Angelone, 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 precise computational models and experimental measurements applied to several areas of clinical significance, including the: 1) analysis of radiofrequency (RF)-induced heating in patients with passive implanted medical devices who undergo magnetic resonance imaging (MRI); 2) analysis of the safety and effectiveness of MR Conditional active implants (e.g., deep brain stimulators and pacemakers) during MRI; 3) RF safety of human subjects during interventional MRI; and 4) analysis of patient safety with respect to gradient-induced heating and unintended nerve stimulation undergoing MRI. These projects are conducted with active collaborations between several researchers, within the FDA and worldwide, at leading academic research institutes and industry organizations.

There is a direct impact to 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 (Critical Path, 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.

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.


Radiofrequency body coil

3D view of the computational model of a radiofrequency (RF) coil system at 64 MHz used in magnetic resonance imaging (MRI). The coil is loaded in the bottom with an ellipsoidal phantom on a supporting table. Computational modeling of coils is extensively used in the evaluation of RF-induced heating during MRI.

Current funding sources

FDA Critical Path Initiative
FDA Office of Women’s Health
Cooperative Research and Development Agreement (CRADA) – Imricor Inc.

Personnel

FDA Staff:
Leonardo Angelone, Ph.D.
Howard Bassen
Maria Ida Iacono, Ph.D.
Wolfgang Kainz, Ph.D.
Sunder Rajan, Ph.D.

Research Fellows: 
Kyoko Fujimoto, Ph.D.
Peter Serano

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)

Public domain software

Virtual Family Website
MIDA Website

Relevant standards & guidances

Reporting of Computational Modeling Studies in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Sta ff

Selected peer reviewed publications

Page Last Updated: 05/08/2017
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