FDA OKs implantable device software tool for MRI

2016 09 02 09 28 19 895 Fda Logo 400

The U.S. Food and Drug Administration (FDA) has qualified a modeling tool from IMAnalytics for assessing how active implantable medical devices would react to radiofrequency (RF) fields during MRI scans.

IMAnalytics is a module of the Sim4Life (v3.4+) software platform that is designed to calculate in vivo response of an elongated implanted device to RF fields during MRI scans. IMAnalytics includes MRIxViP for 1.5- and 3-tesla scanners. MRIxViP 1.5T/3.0T is a pair of standard precomputed libraries of RF-induced electromagnetic field (EMF) distributions inside the human body caused by exposure to a set of RF birdcage coils. The coils are used in both MRI systems with eight different human anatomical models.

The FDA recommends that MRI manufacturers in the agency's medical device development tool (MDDT) program review the MDDT qualification summary for this tool, which presents scientific evidence that served as the basis of the qualification decision.

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