EMPIR project tools first of their kind to be qualified by the US FDA

MRI scan

EMPIR project develops procedures that allow medical implant manufacturers to demonstrate compliance with MRI safety regulations

Of the 50 million European citizens carrying medical implants, the majority will at some point receive an MRI (Magnetic Resonance Imaging) scan. Due to MRI magnetic field and radio wave interactions with some implants, product compatibility is a key consideration for patient safety. Scanning interference hazards and time-consuming compliance testing methods that discourage manufacturers from creating new products for the implant market could be reduced with the help of novel tools and methodologies to prove compliance with regulations.

EMPIR project Procedures allowing medical implant manufacturers to demonstrate compliance with MRI safety regulations (17IND01, MIMAS) has supported the development of test methods to demonstrate implant compatibility with MRI scanning for improved patient safety. By improving models of human subjects with implants, and validation of computer modelling by comparison with test implant measurements, the research results will feed into new and existing international standards for MRI safety regulations. With an additional, simpler compliance-checking process for small implants (< 10 cm), many European manufacturers will benefit from the outcomes of this project.

EMPIR project partner ZMT Zurich MedTech AG, together with its research partner IT’IS Foundation, has developed a toolset for the automatic extraction of electromagnetic field data from large precomputed databases of simulated patient exposures. This toolset, consisting of ZMT’s Sim4Life IMAnalytics and the MRIxViP1.5T and MRIxViP3.0T exposure libraries, have been qualified by the U.S. Food and Drug Administration (FDA) as the first computational Medical Device Development Tool. Within EMPIR, these software tools were verified, validated and applied for evaluations that will allow the identification of worst-case exposure scenarios. More importantly, however, they are commercially available to implant manufacturers, resulting in an accelerated development phase for their new products including faster and more predictable regulatory approval.

Project Coordinator Bernd Ittermann from PTB said

‘The qualification of ZMT’s software tool, IMAnalytics with MRIxViP and BCLib, as a ‘Medical Device Development Tool’ by the US Food and Drug Administration is a major breakthrough on multiple levels. For implant manufacturers, this means a clear roadmap and a predictable outcome for their regulatory approval procedure. For our scientific community this means that numerical simulations, one of the most powerful research tools at our hands, have now received formal accolades by a heavyweight regulatory agency. And for the millions of implant carriers in our society, this means that access to MRI scanning will become easier and safer for them. I am glad that our EMPIR project was able to contribute to that development’.

This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.

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