# Assessing RF heating of active implantable medical devices in low-field MRI systems

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2024 · $582,438

## Abstract

PROJECT SUMMARY Implantable medical devices are on the rise, both in the US and worldwide. Over 12
million Americans rely on a cardiac or neuromodulation device, and this number increases by 100,000 every
year. Roughly 75% of these patients will require an MRI at some point, many multiple times. Yet, the
radiofrequency (RF) fields of MRI can interact harmfully with these devices, causing thermal injuries. This
restricts MRI access for most. The rise of low-field MRI scanners, operating at 0.55 T and below, offers
promise due to reduced costs and siting advantages. However, there's an alarming lack of data on their RF
safety. This absence of knowledge is not merely academic; it bears direct, tangible consequences. Our
preliminary findings paint a complex picture: some implants in these low-field scanners experience
substantially greater RF heating compared to a 1.5T MRI, while others are markedly safer. This disparity
signifies not only heightened risks of injury for some patients but also squandered chances for others who
might safely access essential imaging. With the FDA's recent endorsement of these scanners, there's an
urgent need to generate thorough, evidence-based knowledge about their RF safety, ensuring we fully harness
their benefits without jeopardizing patient welfare. In direct response to this need, we propose a to leverage our
expertise in MRI computational modeling and safety assessment and our access to state-of-the-art deep brain
stimulation (DBS) and cardiovascular implantable electronic devices (CIEDs) to perform a rigorous and
unbiased evaluation of RF heating of DBS and cardiac devices during MRI at 0.55 T. Our team, with ten years
of experience in MRI safety, is ideally suited to address this urgent requirement swiftly. Over the last three
years, we've forged critical alliances with leading implant manufacturers and gained unique access to the
designs of the latest low-field systems. This combination of expertise and privileged access allows us to
achieve results faster than traditional timelines. In this 3-year R01 project, we will conduct a thorough
assessment of RF heating effects for deep brain stimulation (DBS) and cardiac implantable devices during
0.55 T MRI scans. Combined, these devices represent 80% of the active implant market. Our approach will
utilize, validate, and implement RF heating test methods from ISO TS 10974—a robust testing procedure
honed globally for two decades and now required by the FDA for MR-conditional labeling. Specifically, our
objectives are: To create and validate models that consistently forecast RF exposure levels during 0.55 T MRI
(Aim 1). To employ these confirmed models to ascertain RF heating of DBS and CIEDs in both adult and
pediatric subjects (Aim 2). To formulate tables that anticipate age and device-specific temperature increases in
tissue based on imaging landmarks and pulse sequence metrics (Aim 3).

## Key facts

- **NIH application ID:** 10944747
- **Project number:** 1R01EB036272-01
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Laleh Golestani Rad
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $582,438
- **Award type:** 1
- **Project period:** 2024-08-06 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10944747

## Citation

> US National Institutes of Health, RePORTER application 10944747, Assessing RF heating of active implantable medical devices in low-field MRI systems (1R01EB036272-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10944747. Licensed CC0.

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