InSilicoMRI is a module for the investigation of the radiofrequency (RF)-induced heating of passive devices in a 3T MRI scanner.
One of the possible risks posed to a patient with implanted devices during MRI is that conductive structures may pick up RF-energy during the exposure, and locally deposit it as heating in tissue near the implant. To assess the compatibility level, the manufacturer of the medical device has to perform tests to predict the hazard in the worst-case exposure scenario. InSilicoMRI is designed to study the MRI compatibility, for different exposure conditions, of implantable devices (e.g. stents) with different dimensions, configurations or designs.
InSilicoMRI has been implemented in collaboration with the FDA and ANSYS to support the broadening use of computer modeling and simulation for electromagnetic safety analysis prior to a medical device submission. The models used within the simulation (stent, phantom, and RF coil) were provided by the Center for Devices and Radiological Health within the U.S. Food and Drug Administration (FDA-CDRH). The simulation steps are designed to replicate the ASTM F2182-11a Standard.