In December 2019, the U.S. Food and Drug Administration (FDA) approved ZMT Zurich MedTech AG's Sim4Life IMAnalytics Module, including the IT’IS Foundation field exposure libraries MRIxViP1.5T and MRIxViP3.0T and the BCLib body coil libraries. This joint effort between ZMT and IT'IS resulted in the first computational Medical Device Development Tool (MDDT) qualified by the FDA. It marked a key milestone as it greatly simplifies and accelerates the standardized procedures required for proving magnetic resonance (MR) safety of active implantable medical devices (AIMDs), such as pacemakers or neurostimulators.
Today, we are thrilled to report that FDA’s MDDT qualification has been extended to also include passive implant evaluations according to the latest ASTM standard (ASTM F2182-19e2), with IMAnalytics V3.0 together with the new MRIxViP1.5T/3.0T V2.1 libraries. Note that the qualified context of use now also encompasses the Tier 2 as well as Tier 3 approaches defined in Clauses 8 and 15 of ISO 10974.The most important new feature in IMAnalytics V3.0 allows users to obtain averaged electric fields in human computational models, typically over any 10 g of tissue, in a region of interest. This is required as input for Tier 2 evaluations per ISO 10974. Even more important is that it provides the needed information now required by ASTM F2182-19e2, namely that the evaluation in the ASTM phantom shall be supported with computational evaluations in patient phantoms in realistic clinical settings to ensure that the ASTM phantom fields are conservative, or to scale the results if they are not.
Furthermore, in addition to the eight anatomical phantoms already included in the V1.0 library, the MRIxViP V2.1 libraries now also include the four latest Virtual Population models from IT’IS, i.e., Korean female model Yoon-sun and three morphed models to extend population coverage: a slimmer Fats (body mass index (BMI) 29, down from 36), and two heavier Ellas (BMI 26 and 30, up from 22). We have also updated the exposure data for Fats based on the updated Fats V3.2 model.
IMAnalytics V3.0 may be used together with MRIxViP V1.0, and likewise IMAnalytics V2.0 may be used together with MRIxViP V2.1, i.e., the current submission is fully compatible with the previously qualification.
Finally, we are happy to have another important announcement for the users of our experimental tools as we have created MRIxLAB database for easy, fast, reliable and error-proof validation of the transfer functions. It integrates with ZMT's Test Field Diversity system (TFD System) and IMAnalytics Suite.
We are very proud about these latest successes and are happy to answer any questions you may have. The updated Summary of Evidence and Basis for Qualification (SEBQ) report is available here. For more information, please contact us at email@example.com.