Fully automated Tier 3 analysis of radio frequency (RF)-induced local power deposition at the electrodes of implantable devices for millions of excitations. IMAnalytics and MRIxViP are qualified by the FDA for MRI safety evaluations.
IMAnalytics is a novel software platform solution for the comprehensive safety evaluation of implantable devices. The module is designed to characterize the RF-induced heating at the distal electrodes of implantable devices, as well as the voltage at the lead terminals of the pulse generator, using the Tier 3 approach as defined in ISO 10974, and to extract the RF-induced E-field in a region of interest for use in the Tier 2 approach of ISO 10974, or for scaling of ASTM F2182 phantom measurements.
IMAnalytics evaluation tool and the IT'IS field libraries MRIxViP1.5T/3.0T are the first FDA-approved computational modeling Medical Device Development Tool (MDDT). Report
Each released version of IMAnalytics has been extensively tested and validated.
The verification benchmarks use as reference either analytic results from simple setups or results produced by different implementations of similar algorithms. When possible, all the verification steps are automated in such a way that they can be run for every update of the software.
Our approach combines some simplified test fixtures with realistic scenarios. In the first case, the reference results are derived analytically while in the second case they are obtained using an alternative algorithm or implementation.
Full verification and validation (v&v) documentation, including the descriptions of our test fixtures and validation criteria, is provided to all customers.
Histogram of Tier 3 deposited power for a given position of the anatomical models.
Selection of anatomical model and routings.
Tier 3 deposited power for different imaging positions.