MRI safety software tool receives FDA's qualification for MDDT
USA: The US Food and Drug Administration (FDA) has given the regulatory go-ahead to a software tool designed to help users analyze the safety of MRI environments.
According to FDA, the tool 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.
The MDDT program supports innovation in medical device development and regulatory science, helping to bridge the gap between research of medical devices and delivery of devices to patients. The program provides FDA with qualified tools that medical device sponsors can utilize during the evaluation and development of medical devices. To earn qualification, FDA evaluates the submitted tool and reviews available supporting evidence to determine if the tool can provide scientifically plausible measurements.
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 the development and regulatory evaluation of medical devices. More information on the MDDT program is available on the FDA's website.
"We would like to thank the FDA for the opportunity to participate in the MDDT program", says David Gross, Director of MRI Safety Evaluations and Engineering Simulations at MED Institute. "We are excited to offer this MDDT to our clients and help them get their products to market faster, at a lower cost, and with better data."