News | January 09, 2007

Report Highlights MR Safety Issues

Jan. 10, 2007 — A report is now available summarizing the findings from a workshop last October sponsored by Biophan Technologies Inc. and the FDA for the purpose of addressing safety issues surrounding MR and implantable medical devices.

Authored by Howard Bassen, Ph.D. of the FDA, Jeffrey Helfer, Biophan VP Engineering, and Andreas Melzer, M.D., CEO of Biophan Europe, the paper — "Biophan Technologies CRADA Workshop on the Safe Use of Implantable Medical Devices in Magnetic Resonance Imaging (MRI) Systems - Summary from Initial Workshop” — is accessible at http://www.biophan.com/crada_workshop0107.

The CRADA titled "Measurements and Computer Modeling to Evaluate the Safety of Medical Implants by Examining Leads of Cardiac Rhythm Management and Neurostimulation Devices in the Presence of Electromagnetic Fields from Magnetic Resonance Imaging," began with a workshop attended by leading device manufacturers and medical, scientific and industry experts from around the world. Participants discussed cardiac rhythm management and neurostimulation devices and their behavior in an MRI environment. The group focused on factors perceived as most relevant to device safety, including lead heating and induced voltages, and how to properly measure these effects.

The report summarizes the many safety-related factors identified by workshop participants, including device design, MRI scanner, and patient parameters.

The next phase of the CRADA will involve experiments to identify worst-case conditions for testing MRI safety, to establish device safety guidelines, and to define measurement methods.

Related Content

Stress Cardiac MRI Shows High Prognostic Value for Suspected Ischemia Patients
News | Magnetic Resonance Imaging (MRI) | September 17, 2018
Raymond Kwong, M.D., MPH, from the Harvard Medical School recently presented his findings on a study of how single-...
Rapid Cardiac MRI Technique May Cut Costs, Boost Care in Developing World
News | Magnetic Resonance Imaging (MRI) | August 29, 2018
A newly developed rapid imaging protocol quickly and cheaply diagnosed heart ailments in patients in Peru, according to...
Videos | Magnetic Resonance Imaging (MRI) | August 13, 2018
Haojie Wang, M.D., director of advanced cardiovascular MRI and a member of the heart valve clinic at Baylor Scott Whi
High Prevalence of Atherosclerosis Found in Lower Risk Patients
News | Magnetic Resonance Imaging (MRI) | June 08, 2018
Whole-body magnetic resonance angiography (MRA) found a surprisingly high prevalence of atherosclerosis in people...
A cardiac MRI scanner at the Houston Methodist DeBakey Heart and Vascular Center. There is growing concern that gadolinium contrast may cause chronic health problems in some patients.

A cardiac MRI scanner at the Houston Methodist DeBakey Heart and Vascular Center. There is growing concern that gadolinium contrast may cause chronic health problems in some patients.

Feature | Magnetic Resonance Imaging (MRI) | February 28, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
Contrast-Free Cardiac MRI May Better Assess Need for Mitral Valve Surgery
News | Magnetic Resonance Imaging (MRI) | February 27, 2018
A new study published in the Journal of the American College of Cardiology confirms non-invasive cardiac magnetic...
The FDA has cleared the Toshiba Vantage Galan 3.0T XGO Edition MRI from Canon Medical Systems.
Technology | Magnetic Resonance Imaging (MRI) | February 12, 2018
February 12, 2018 — Physicians now have access to more neuro and cardiac ...
Russian Team Developing New Technology to Significantly Reduce MRI Research Costs
News | Magnetic Resonance Imaging (MRI) | January 16, 2018
January 16, 2018 — Researchers from the NUST MISIS Engineering Center for Industrial Technologies in Russia have deve
Videos | Magnetic Resonance Imaging (MRI) | December 13, 2017
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pitt
Overlay Init