Extended MDDT Tool Qualified by FDA

ZMT and the IT’IS Foundation continue to join forces in the development of tools for MR-safe implant evaluations. Today, we are very pleased to announce that the U.S. Food and Drug Administration (FDA) has extended the qualification of our Medical Device Development Tool (MDDT), which now not only includes MR safety assessment of elongated active medical implants, but also passive and short active implants (ASTM F2182-19e2 and ISO 10974).

 

Also, we are happy to announce the new MRIxLAB database, which works with the IMAnalytics Suite to accelerate active implantable medical device (AIMD) model validation with the Test Field Diversity system in the MITS.

More information about the latest Sim4Life Module IMAnalytics V3.0 and the MRIxViP1.5T/3.0T V2.1 and MRIxLAB libraries can be found

 

https://zmt.swiss/news-and-events/news/sim4life/fda-extends-mddt-qualification-to-imanalytics-v3-0-and-mrixvip-v2-1/

 

If you want to know more details, please contact us

+8863-3631901#134 / inem@auden.com.tw

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