|
 
 Today, the U.S. Food and Drug Administration (FDA) announced a new qualification tool through the voluntary Medical Device Development Tools (MDDT) program. The new MDDT is a computational modeling and simulation tool that can predict the temperature rise in tissue around certain metallic orthopedic implants during a magnetic resonance imaging (MRI) scan.
This MDDT tool:
- Is a non-clinical assessment model (NAM) that can predict the rise and distribution of temperature in bone around metallic femoral nails when exposed to radio frequencies during a MRI scan.
- Was developed using data from female patients but has regulatory utility for assessing temperate rise in all adults, regardless of sex.
- Can identify the appropriate worst-case implant size, configuration, and orientation, and an allowable scan protocol by performing multiple simulations to determine the radio frequency induced temperature rise based on scan times and rest times. Additionally, the tool’s ability to predict temperature rise can be used to help identify safe MRI scan protocols for the purposes of MR conditional labeling.
Questions?
If you have questions about the MDDT Program, contact MDDT@fda.hhs.gov
|
|
|
|
