MED Institute, Inc. And FDA Sign Collaborative Research Agreement To Assess Radio Frequency Heating Safety Of Passive Implants

WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--The Center for Devices and Radiological Health (CDRH), a group within the U.S. Food and Drug Administration (FDA), 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.

For more information visit https://www.medinstitute.com.

About MED Institute

MED Institute has for over 30 years supported development of medical products assisting manufacturers to make them available to clinicians and patients.