Virtual MRI Safety Evaluations of Medical Devices

U.S. Food and Drug Administration sent this bulletin at 11/16/2021 02:48 PM EST

If your email program has trouble displaying this email, view as a webpage.
FDA - Center for Devices and Radiological Health

Bookmark and Share

“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.

Read More

Questions?

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