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25/05/2021
Sim4Life

FDA Extends MDDT Qualification to IMAnalytics V3.0 and MRIxViP V2.1

FDA Qualification of the ZMT & IT’IS MDDT toolset, IMAnalytics with MRIxViP1.5T/3.0T and BCLib, now also includes passive implants (ASTM F2182-19e2) and Region-of-Interest Field Extraction for ISO 10974 Tier 2

In December 2019, the U.S. Food and Drug Administration (FDA) approved ZMT’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 IT’IS and ZMT 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 the 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 hereFor more information, please contact us at info@zmt.swiss.

Sim4Life

14/05/2021

Contact
info@zmt.swiss

 

Sim4Life at the 2021 ISMRM & SMRT Annual Meeting & Exhibition

Sim4Life will be showcased by several users at the Virtual ISMRM 2021, don’t miss their contributions!

 
Sim4Life

11/05/2021

Contact
info@zmt.swiss

 

Sim4Life V6.2.1 Maintenance Release

The Sim4Life Team announced the release of Sim4Life V6.2.1, an updated version of Sim4Life V6.2.

 
Sim4Life

16/03/2021

Contact
info@zmt.swiss

 

IT’IS Releases Four New Mouse Models Segmented From Whole-Body MR Images

The IT’IS Foundation has released four new mouse models segmented from magnetic resonance imaging data. All four models are optimized for Sim4Life.

 
Sim4Life

23/02/2021

Contact
info@zmt.swiss

 

Sim4Life Release V6.2

ZMT has deployed a new release of its Sim4Life platform. V6.2 not only comes with a smoother look and feel and a better user experience but also with important new features, refinements, and bug fixes. 

 
Sim4Life

16/02/2021

Contact
info@zmt.swiss

 

IT’IS Releases NeuroRat V4.0, the First Neuro-Functionalized Animal Model

Today, the IT’IS Foundation announced the release of the advanced computational NeuroRat V4.0 model with detailed neuroanatomy that features peripheral nerve trajectories and a co-registered brain atlas model (Waxholm Space Atlas) ‒ another important step in their efforts to support and partially replace laboratory experiments. The anatomy is based on high-resolution computed tomography and structural magnetic resonance imaging data acquired by the Animal Imaging Center at ETH Zurich and the University of Zurich.

 
Sim4Life

19/01/2021

Contact
info@zmt.swiss

 

IT’IS Distributes New Anatomical Pediatric Model MARTIN V1.0 and Releases ViP Hand Library V3.x

IT’IS Distributes New Anatomical Pediatric Model MARTIN V1.0 and Releases ViP Hand Library V3.x

 
Sim4Life

27/10/2020

Contact
info@zmt.swiss

 

Sim4Life Release V6.0

ZMT is pleased to announce Sim4Life V6.0, our latest answer to market and customer requirements for both new, effective R&D features and enhanced compliance evaluation tools.

 

 
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