IMAnalytics

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 Module: automated Tier 3 analysis of implants (PiX transfer functions) with user-defined parameter ranges (e.g., normalizations, coil dimensions, shimming angles, clinical routings, subsets of the patient population and landmarks).

Product description

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

Features

Fully compatible with the exposure field libraries MRIxViP of the IT’IS Foundation.
Fully compatible with MRIxLAB dataset from the IT’IS Foundation of pre-computed induced fields in the Test Field Diversity
Streamlined graphical user interface (GUI) – with the tabs removed, all tools available from the main windows, and Jupyter notebooks that can be launched directly from the main interface
Results, including all plots, raw data, and study parameters, are conveniently exported packaged into a single zip file for full traceability and easy archiving
Preprocessing of terabytes of electromagnetic (EM) field data from many combinations of birdcage types, anatomies, landmark positions and implant routing paths.
Direct input of the transfer function of the implanted device from piX system.
Different polarizations and exposure conditions by sweeping through many independent excitation settings of the I and Q channels.
Efficient evaluation of millions of exposure scenarios and extraction of relevant statistical data on deposited power.
Export of results, including all plots, raw data, and study parameters, into a single zip file for full traceability and easy archiving
Evaluation of deposited power or induced voltage at different operating modes (normal, first level controlled).
Computation of Tier 3 induced voltage
Different limits defined in terms of whole-body specific absorption rate (SAR), partial-body SAR, head SAR or B1 field values.

Application

MR-safety with respect to RF-induced heating of structures such as leads for cardiac pacing/sensing, implantable cardioverter defibrillator (ICD), spinal cord stimulation (SCS), and deep-brain stimulation (DBS) systems.
Prediction of the ISO 10974 Tier 3 in vitro deposited power or induced voltage for different test routings, incident field polarizations, and tissue-simulating media, making the experimental transfer function validation process faster and error-proof

Verification

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.