MORE TESTING NEEDED ON MRI SAFETY WITH IMPLANTABLE DEVICES

The poor understanding of device performance in magnetic resonance imaging (MRI) environments means that implantable devices "remain contraindicated for use with MRI," Biophan Technologies Vice President of Engineering Jeffrey Helfer said Jan. 8.

"Many people either miss an opportunity to have an MRI because of the presence of an implant or receive a scan despite the presence of an implanted device, creating the potential for MRI-induced injury," he added.

Biophan convened a joint workshop with the FDA in October to examine how implanted cardiac rhythm management and neurostimulation devices respond when patients undergo MRI scans.

The workshop was part of a Cooperative Research and Development Agreement between the firm and the FDA's Office of Science and Engineering Laboratories. (http://www.fdanews.com/ddl/34_3/)