Implant MRI Safety

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, a MITS 1.5 and 3T system, the latest DASY6 RX90L with DASY52NEO licenses, and a wide range of specialized probes, including hardened probes designed specifically for MRI environments. With more than 100 Sim4Life licenses, including the Virtual Population 3.x and multiple animal models, and several high performance computers (HPC) ranging from graphics processing unit (GPU) clusters to supercomputers, our interdisciplinary research team can tackle highly specific and complex research tasks with superior innovation and efficiency – while ensuring compliance to national and international standards.

• 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.

As many of the current methods for demonstrating MRI safety of implants are still too conservative (i.e., overestimating the risks and thereby hindering technology unnecessarily) and - most importantly - incomplete, the IT'IS Foundation is committed to expanding its activities collectively with potential partners. We are also interested in answering open questions related to the interference of other strong EM sources with implants, such as wireless power transfer systems.

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 customized@itis.swiss.