Medical Devices SIG Webinar
Computational Modeling for Regulatory Science in the Office of Science and Engineering Laboratories at the FDA
Recorded: December 7, 2016
ModeratorWalt Baxter, PhDSenior Principal Scientist, Medtronic
SpeakerLeonardo Angelone, PhDResearch Biomedical Engineer, Center for Devices and Radiological Health,
Office of Science and Engineering Laboratories, U.S. Food and Drug Administration
The Computational Modeling for Regulatory Science at the FDA webinar will give BMES Medical Devices SIG members a high-level overview of the Agency’s research around advancing knowledge on the complex interactions between electromagnetic fields and human body. The research combines anatomically precise computational models and experimental measurements applied to several areas of clinical significance, including: 1) analysis of radiofrequency (RF)-induced heating in patients with implanted medical devices undergoing Magnetic Resonance Imaging (MRI); 2) RF safety of human subjects during interventional MRI; 3) analysis of safety and effectiveness of MR Conditional deep brain stimulators. These projects are conducted with active collaborations with several researchers both within the FDA and worldwide at leading academic research institutes and industry organizations. These projects have direct impact to the regulatory mission of the Agency, because anatomically precise numerical models are used by industry in pre-market evaluation of safety and effectiveness of their medical devices. The accuracy of these models and the validation methods are often fundamental issues in the ongoing regulatory evaluation.
This copyrighted webinar is produced by the Biomedical Engineering Society (BMES). Any broadcast or transmission without the written consent of BMES is prohibited.