A software tool designed to help users analyze the safety of MRI environments has been given the regulatory go-ahead by the U.S. Food and Drug Administration (FDA).
The FDA said it qualified the Virtual MRI Safety Evaluations of Medical Devices tool under its Medical Device Development Tools (MDDT) program. The tool can help users maintain safety in the MRI environment through the following:
- Predicting interactions between medical device implants and electromagnetic fields in the MRI environment
- Predicting temperature rise in tissue caused by radiofrequency (RF) heating near electrically passive fully implanted medical devices such as orthopedic joint prostheses and cardiovascular stents
- Generating results more efficiently compared with bench testing medical devices.
Regulatory paperwork for the tool was submitted by MED Institute, which notes that the tool is a nonclinical assessment model (NAM) that uses computer modeling and simulation to predict the interactions of medical devices in the MRI environment.
In submitting the application to the FDA, MED Institute noted that there has been growth both in the number of MRI scanners in use and the number of patients with implanted medical devices who may require MRI scans at some point during their lives. The tool can help predict whether MRI can be used safely in these patients.
The MDDT program is designed to facilitate development and regulatory evaluation of medical devices. More information on the MDDT program is available on the FDA's website.