Numeral Magnetic Resonance Implant Safety.
Assess the injury risk and thermal outcomes of RF exposure in MRI scanners for patients with stent, prosthesis, 3D printed implant
Upload your own device geometry or choose one from the library and set up a compatibility test simulation for 1.5T and 3T systems
Collect specific absorption rate (SAR) and temperature results for different exposure setups
Create a results’ report following the FDA guidelines for regulatory submissions
Simulation has proven that it can replicate the standard tests required by regulatory bodies with accuracy. Outcomes can be estimated in a few hours even for a family of devices, taking into consideration geometrical features, materials, orientation of the device and applied RF field strength.
The absorption of radiofrequency (RF) energy during a magnetic resonance imaging (MRI) procedure may cause tissue heating in the vicinity of a conductive implanted device, potentially causing patient harm. The compatibility assessment of such devices is typically performed in bench requiring high testing costs and resulting in long time to market.
Computational Modeling & Simulation (CM&S) can be used by medical device manufacturers to increase the efficiency of the device R&D workflow. Such numerical models can be used to assess the RF-induced heating of implanted devices and to identify worst-case configurations within a given line of implants. However, despite the use of in-silico tools, a standard for in-silico testing of such problematics is still missing.
Within the insilicotrials.com platform, as part of the InSilicoMRI library, NuMRis is a web-based tool that automates the set-up and solution of RF-heating analysis through ANSYS Workbench. The automated workflow is in line with regulatory guidelines and existing standards for in-vitro testing of such problematics (Standard Test Method ASTM F21824).
NuMRis has been implemented in collaboration with FDA and ANSYS and is based on models of the RF exposure system provided by the Center for Devices and Radiological Health within the U.S. Food and Drug Administration (FDA-CDRH). The simulation steps are designed following the ASTM F2182-19e2 Standard.