On December 12, 2019 the U.S. Food and Drug Administration (FDA) announced the acceptance of ZMT’s Sim4Life IMAnalytics and the field exposure libraries MRIxVIP1.5T and MRIxViP3.0T from the IT’IS Foundation as a Medical Device Development tool (MDDT). This qualification marks a major breakthrough for Z43 in our endeavors to develop reliable and qualified tools for supporting medical device development and treatment planning and improving and ensuring patient safety.
The MDDT label of our software tools certifies that evaluations of the health risks posed by active implantable medical devices (AIMDs) to patients undergoing magnetic resonance imaging (MRI) diagnostics are traceable, easy-to-conduct, and standardized at the most comprehensive level. The combined usage of IMAnalytics and MRIxViP1.5/3.0T guarantees the quality of the MRI safety evaluations and enables the medical device industry to accelerate the approval process with even enhanced quality of the risks evaluation and allows regulators to focus on other safety-relevant aspects of the approval submission.
According to Edward Margerrison, Ph.D., Director, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH), FDA, “IMAnalytics with MRIxViP1.5T/3.0T and BCLib Toolset may be used in the premarket submissions of AIMDs to obtain the statistical distribution of the in vivo deposited power and/or induced terminal voltage to support MR Conditional labeling of these medical devices for 1.5T or 3T MR scanners, according to the Tier 3 approach defined in ISO/TS 10974:2018”. In other words, applying a qualified MDDT tool as non-clinical assessment model eliminates much of the risk and uncertainty manufacturers often experience in product development. Learn more about the FDA’s MDDT program here.
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