” In #MRI environment, the radiofrequency heating of #implanted medical devices can be significant, and may be a risk for patients. This heating is acute and depends on multiple factors, thus for multi-configurational devices, it is often impossible to predict the worst-case by a simple rationale.
At Healtis, we have a expert team and specific tools dedicated to the numerical modeling of heating due to the radiofrequency fields in MRI.
For implantable passive devices, numerical modeling allows us, for example, to predict the worst-case across complex ranges of devices, and also to determine the «hots spots» (Points on the device where the heating is the greatest). These hot spots are the location where the device should be monitored during actual MRI tests.
In 2016, the FDA published a guidance document specifically dedicated to this issue, encouraging medical device manufacturers to perform numerical simulations for passive devices with multiple configurations (joint prostheses, spinal implants or any device whose final configuration may vary).
Our numerical modeling services fully meet the recommendations set out by this guidance document, allowing you to conduct a thorough and rigorous study on your device. By relying on our expertise in numerical modeling, you can be assured of meeting the regulatory requirements for the evaluation of Radiofrequency heating in MRI.
Any questions about this service? Reach out now at sales@healtis.com