FDAnews Device Daily Bulletin

BIOPHAN WILL PARTNER WITH FDA TO STUDY MRI SAFETY FOR PATIENTS WITH DEVICE IMPLANTS

May 3, 2006
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Biophan Technologies has entered into a cooperative research and development agreement (CRADA) with the FDA to improve patient safety in magnetic resonance imaging (MRI) environments, the company announced today.

Under the agreement, Biophan will collaborate with the science and engineering laboratories in the Center for Devices and Radiological Health (CDRH) to develop safety assessment guidelines and standards for cardiac pacemaker and neurostimulation leads used in the MRI environment.

The collaboration could lead to a new generation of MRI-safe implantable medical devices, as well as safer MRI technologies for patients implanted with such devices, the company said.