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Biophan, FDA enter into research partnership to improve MRI safety
By Lisa Kerner
Erie, Pa., May 2 - Biophan Technologies, Inc. has entered into a cooperative research and development agreement with the Food and Drug Administration to help improve patient safety in Magnetic Resonance Imaging (MRI) environments.
Under the agreement, Biophan will work with the FDA's Center for Devices and Radiological Health to develop guidelines and standards for assessing the safety of cardiac pacemaker and neurostimulation leads used in the MRI environment.
"Biophan is very gratified to be working with the FDA to research these areas and to help to extend the benefits of MRI to all those who need it," chief executive officer Michael Weiner said in a company news release.
"The sad reality is that more than half of all recipients of pacemakers and other implanted devices today are estimated to be denied access to MRI post-implantation. This amounts to hundreds of thousands of people who are denied the benefits of MRI."
The relationship between Biophan and the FDA could lead to a new generation of MRI-safe medical devices and new or modified MRI technologies, officials said.
Biophan is Rochester, N.Y., medical technology company.
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