Implant MRI Safety



Demonstrating the safety of implants with long leads (a pacemaker and a deep brain stimulator) during MRI scans in the Virtual Population.






Simulation of local RF heating of a pacemaker lead in a 1.5T MRI.






Multiple routing paths can be efficiently screened in parametric simulations with the help of precomputed libraries.

Implant MRI Safety

Expertise and Infrastructure

The IT’IS Foundation runs a dedicated group for customized research solutions in the area of MRI implant safety. IT’IS is your partner of choice as it (1) has pioneered the development of robust methods for the safety testing of Active Implantable Medical Devices (AIMD) and has contributed significantly to ISO/TS 10974, (2) applied these methods to a wide range of medical implants, (3) has detailed knowledge about the intricacies of regulatory agencies and the corresponding processes due to their active participation and membership in IEC/ISO standard groups, as well as (4) experience in interacting with the US Food and Drug Administration (FDA), and other regulators on numerous successful projects.

The group’s Yellow Submarine Laboratory is equipped with the most advanced tools including a PiX system, MITS-1.5T, -3T, -TT, -HFR, and -Gradient systems, the latest DASY6 RX90L with DASY52NEO licenses, and a wide range of specialized probes for E-field, SAR, H-field and voltage, including hardened probes designed specifically for MRI environments. 

The safety analysis as described in Tier 3 of ISO 10974 requires repeating the power deposition assessment for a wide range of computational models, for all the possible ways of clinical implantation in them, and for all possible exposure scenarios. With the MRIxViP exposure library and the IMAnalytics module of Sim4Life, this becomes a simple, reliable and traceable procedure. From the AIMD response model, the incident field distributions and the implants’ routing trajectories, IMAnalytics automatically performs the statistical analysis of power deposition at the tip of the AIMD lead in all possible scenarios. The results can be exported and included in regulatory submission reports.

IMAnalytics and MRIxViP are qualified by the FDA for MRI safety evaluations.


Select Customized Research Projects of the Past Years
  • Studied the interaction between the MRI fields and implants, and methods to mitigate RF pickup;
  • Developed methods for demonstrating MRI safety of cardiovascular implants (in collaboration with a leading manufacturer);
  • Demonstrated MRI safety of cochlear implants based on temperature evaluations using Tier-4 of IEC/ISO 10974 (i.e., full 3D simulations);
  • Developed methods for demonstrating MRI safety of neuro-stimulators, including support (reports/hearing) during the FDA submission process;
  • Carried out a pilot study for demonstrating the safety of a class of passive implants without evaluating individual implants.



We look forward to discussing with you how we can best support your R&D initiatives and regulatory submissions – simply call us at +41 44 245 96 96 or send us an email at



Yao, A., Zastrow, E., Cabot, E., Lloyd, B., Schneider, B., Kainz, W. & Kuster, N. Anatomical Model Uncertainty for RF Safety Evaluation of Metallic Implants Under MRI Exposure. Bioelectromagnetics, 40(7):458-471, 2019, doi:10.1002/bem.22206
Yao, A., Zastrow, E., Neufeld, E. & Kuster, N. Efficient and Reliable Assessment of the Maximum Local Tissue Temperature Increase at the Electrodes of Medical Implants under MRI Exposure. Bioelectromagnetics, 40(6):422-433, 2019, doi:10.1002/bem.22208
Liorni, I., Neufeld, E., Kühn, S., Murbach, M., Zastrow, E., Kainz, W. & Kuster, N. Novel Mechanistic Model and Computational Approximation for Electromagnetic Safety Evaluations of Electrically Short Implants. Physics in Medicine and Biology, 63(22), 2018
Yao, A., Zastrow, E. & Kuster, N. Data‐Driven Experimental Evaluation Method for the Safety Assessment of Implants With Respect to RF‐Induced Heating During MRI. Radio Science, 53(6):700-709, 2018, doi:10.1029/2017RS006433
Corcoles, J., Zastrow, E. & Kuster, N. On the estimation of the worst-case implant-induced RF-heating in multi-channel MRI. Physics in Medicine and Biology, 62(12):4711-4727, 2017
Murbach, M., Neufeld, E., Cabot, E., Zastrow, E., Corcoles, J., Kainz, W. & Kuster, N. Virtual Population-Based Assessment of the Impact of 3 Tesla Radiofrequency Shimming and Thermoregulation on Safety and B1+ Uniformity. Magnetic Resonance in Medicine, 76(3):986-997, 2016
Corcoles, J., Zastrow, E. & Kuster, N. Convex Optimization of MRI Exposure for Mitigation of RF-Heating from Active Medical Implants. Physics in Medicine and Biology, 60(18):7293-7308, 2015
Murbach, M., Zastrow, E., Neufeld, E., Cabot, E., Kainz, W. & Kuster, N. Heating and Safety Concerns of the Radio-Frequency Field in MRI. In Current Radiology ReportsCurrent Radiology Reports, 3(12), Springer, 2015, doi:10.1007/s40134-015-0128-6
Kyriakou, A., Christ, A., Neufeld, E. & Kuster, N. Local Tissue Temperature Increase of a Generic Implant Compared to the Basic Restrictions Defined in Safety Guidelines. Bioelectromagnetics, 33(5):366-374, 2012, doi:10.1002/bem.21695
Neufeld, E., Gosselin, M.C., Murbach, M., Christ, A., Cabot, E. & Kuster, N. Analysis of the Local Worst-Case SAR Exposure Caused by an MRI Multi-transmit Body Coil in Anatomical Models of the Human Body. Physics in Medicine and Biology, 56(15):4649-4659, 2011, doi:10.1088/0031-9155/56/15/002
Neufeld, E., Kühn, S., Szekely, G. & Kuster, N. Measurement, Simulation and Uncertainty Assessment of Implant Heating During MRI. Physics in Medicine and Biology, 54(13):4151-4169, 2009, doi:10.1088/0031-9155/54/13/012


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