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  1. CDRH Research Programs

Magnetic Resonance Imaging (MRI) Safety and Effectiveness

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Sunder Rajan, Ph.D.

Summary

Magnetic resonance imaging (MRI) is a widely used diagnostic modality with an excess of 30 million scans performed every year in the U.S. Although MRI is considered an exceedingly safe modality, there is an underlying potential for injury to patients due to the strong electromagnetic (EM) fields used in MR scanning. In addition, the rapid increase in the number of patients with medical implants who require MRI scans has spawned a new focus in the field of MRI safety, due to the interactions of medical implants with EM fields used during MR scanning. As a result, this has led to an increase in premarket submissions for medical devices that are compatible with the MR environment.

This research area mainly centers on understanding the safety aspects of medical implants and some aspects of MRI applications. Here are some of regulatory science areas covered by this group::

  • Development of underlying tools for studying interactions leading to thermal injury by electromagnetic modeling, laboratory measurements, and thermometry
  • Retrospective evaluation and comparison of testing data to understand trends and effects of passive implants
  • Testing of selected devices in an MRI environment to gain further insights or guide policy (e.g. stents, devices with magnets)
  • Studying the physiological responses of thermal dosing (Brain perfusion imaging)
  • Standardizing MRI methods for screening of silicone breast implants
Virtual model of Body RF coil

3D view of the computational model of a radiofrequency (RF) coil system at 64 MHz used in magnetic resonance imaging (MRI). Computational modeling of coils is extensively used in the evaluation of RF-induced heating during MRI.


Actual Body RF coil

3D view of the physical radiofrequency (RF) coil system at 64 MHz used in magnetic resonance imaging (MRI) available in our laboratory.


Testing of stents

Testing of stents at the bench and in computational modeling for RF exposure during MRI.

This group supports the agency's regulatory and guidance role by advancing knowledge on the complex interactions between electromagnetic fields and human body. These projects are conducted with active collaborations with researchers within the FDA as well as at leading academic research institutes and industry organizations worldwide. Research is funded by 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:
Sunder Rajan, Ph.D.
Howard Bassen
Kyoko Fujimoto, Ph.D.
Wolfgang Kainz, Ph.D.
David Soltysik, Ph.D.

External collaborators

Resource facilities

Relevant standards & guidance

Selected peer review publications