FDA and MED Institute Partner on Metallic Implant MRI Project

The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) has signed a three-year research collaboration agreement with MED Institute, a Cook Group company that supports developers of medical products through the key phases of obtaining market approval.

CDRH and MED Institute will collaborate on a research project to assess the radio frequency (RF) induced heating of passive metallic medical devices during magnetic resonance imaging (MRI). Typical metallic devices including vascular and orthopedic implants will be used to understand RF-induced heating’s dependency on geometrical, material and electrical device characteristics. The information learned will guide engineers in designing appropriate MR safety testing strategies and understanding thresholds for heating.

The results of the study will be shared with the medical device community via peer-review manuscripts and written communications.

MED Institute was established 30 years ago as a resource for Cook Group companies to identify and develop new medical product concepts. This includes new product identification, prototype development, nonclinical Good Laboratory Practice testing, clinical trial management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and technical personnel or professionals, and is headquartered in West Lafayette, Ind.