Diagnostic imaging  

Biophan to study MRI safety with US Food and Drug Agency

8 May 2006

Rochester, N.Y., USA. Biophan Technologies, Inc. (OTCBB: BIPH; FWB: BTN) has entered into a research partnership with the US Food and Drug Administration (FDA) to help improve patient safety in magnetic resonance imaging (MRI) environments.

Under a Cooperative Research and Development Agreement (CRADA), Biophan will collaborate with the FDA's Science and Engineering Laboratories in the Center for Devices and Radiological Health, to help develop guidelines and standards for assessing the safety of cardiac pacemaker and neurostimulation leads used in the MRI environment. The agreement is part of the government's initiative to address these public safety concerns.

"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," said Michael Weiner, CEO of Biophan Technologies. "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. Biophan believes that this is an untenable situation that must be, and can be, effectively remedied. The Company has a wide range of solutions for and has extensive scientific expertise in the issues involved."

The CRADA between Biophan and the FDA could lead to a variety of solutions for the healthcare industry, Mr. Weiner noted, including: a new generation of medical devices, manufactured to be fully MRI safe; enhancements to currently existing medical devices, to enable MRI safety; and either new or modified MRI technologies to enhance the safety of these imaging systems.

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