Dive Brief:

• FDA qualified a tool designed to make it easier for developers of active implantable medical devices (AIMDs) to prepare safety test results, it announced Thursday. 

• The tool, which was developed by ZMT Zurich MedTech, generates statistical data based on clinically relevant scenarios to support the preparation of MRI radiofrequency results. 

• The agency assessed the technology under its Medical Device Development Tools (MDDT) program, which the agency uses to validate products for use in device development and evaluation.

Dive Insight:

Developers of AIMDs need to show what will happen when a patient with the implant undergoes an MRI scan. ZMT has created software that enables device developers to perform those evaluations via a computer.

The product, the IMAnalytics module of ZMT's Sim4Life software, automates the analysis of the radiofrequency-induced heating that can take place when patients with implanted electrodes are put in MRI scanners. In the past, ZMT claims this process took “many months” as thousands of individual simulations needed to be run.

That breadth of simulations is to cover the range of possible types of implants and lead trajectories, patient-to-patient variability in device location and different versions of MRI systems. To cut the time the analysis takes, ZMT has leveraged datasets on MRI scanners and human anatomy.

ZMT filed IMAnalytics for review under FDA's MDDT program earlier this year, leading to a positive decision from the agency this week. FDA concluded the qualification of IMAnalytics “reduces the burden on sponsors preparing MRI [radiofrequency] safety test results.”

FDA qualified the technology with some caveats. The qualification summary states the tool is not suitable for use with AIMDs that stimulate or deliver current when a patient is in the MRI scanner. 

The decision makes IMAnalytics the third product to receive MDDT qualification this year. FDA only qualified two tools across all of 2017 and 2018. The agency published final guidance on the program in 2017.

The upswing in MDDT activity in 2019 has been characterized by a shift in the types of tools qualified by FDA. The two tools qualified in 2017 and 2018 were both questionnaires used to captures views from people living with certain health conditions. This year, FDA has qualified two software modules and a material designed to mimic human tissue in assessments of certain ultrasound devices.