Tuesday, November 16, 2021

Virtual MRI Safety Evaluations of Medical Devices

The tool can predict interactions between medical implants and electromagnetic fields, potentially saving time and resources.

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FDA - Center for Devices and Radiological Health

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"Virtual MRI Safety Evaluations of Medical Devices" Tool Can Predict Interactions Between Medical Implants and Radiofrequency Energy

Medical Device Development Tools Program

The U.S. Food and Drug Administration (FDA) qualified the "Virtual MRI Safety Evaluations of Medical Devices" tool through the voluntary Medical Device Development Tools (MDDT) program. The Virtual MRI Safety Evaluations of Medical Devices tool:

  • Is a non-clinical assessment model (NAM), that uses computational modeling and simulation to predict the interactions between medical device implants and electromagnetic fields in the magnetic resonance (MR) environment.
  • Can reliably predict the temperature rise caused by radiofrequency (RF) heating near electrically passive, fully implanted, medical devices such as orthopedic joint prostheses and cardiovascular stents.
  • Has the potential to more efficiently generate results compared with bench testing certain medical devices.

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Questions?

If you have questions about the MDDT Program, contact MDDT@fda.hhs.gov.


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