[Brainmap]: Leonardo Angelone PhD- Computational Modeling & Measurements for Electromagnetic Safety in MRI: a regulatory science perspective
Abstract
Our group supports the FDA regulatory and guidance role by advancing our knowledge on the complex interactions between electromagnetic (EM) fields and the human body. The research combines anatomically precise computational models and experimental measurements applied to several areas of clinical significance, including the: 1) analysis of radiofrequency (RF)-induced heating in patients with passive implanted medical devices who undergo magnetic resonance imaging (MRI); 2) analysis of the safety and effectiveness of MR Conditional active implants (e.g., deep brain stimulators and pacemakers) during MRI; 3) RF safety of human subjects during interventional MRI; and 4) analysis of patient safety with respect to gradient-induced heating and unintended nerve stimulation undergoing MRI. These projects are conducted with active collaborations between several researchers, within the FDA and worldwide, at leading academic research institutes and industry organizations. There is a direct impact to the regulatory mission of the Agency, as the tools developed by our research are extensively used by industry in pre-market evaluation for the safety and effectiveness of their medical devices.
Webpages
Electromagnetic Modeling Research Program at FDA
Magnetic Resonance Imaging Research Program at FDA
About the Speaker
Leonardo M. Angelone is a Research Biomedical Engineer at the Office of Science and Engineering Laboratories, Center of Devices and Radiological Health, U.S. FDA. Dr. Angelone leads a Research program that focuses on assessment of energy deposition and heating induced in the human body by medical devices using electromagnetic energy. The investigation is based on a combination of anatomically precise computational models and experimental measurements applied to several areas of clinical significance, including RF safety of human subjects during interventional MRI and analysis of safety and effectiveness of MR Conditional deep brain stimulators. The projects, supported by both FDA and external (CRADA) funding, have been carried on in collaboration with groups at leading academic research institutes, including several colleagues at the A. Martinos Center, and industry organizations. The results of the projects have been presented in over 100 peer-reviewed journal articles and conference proceedings, as well as publicly available software. Dr. Angelone completed a Laurea in Electronic Engineering (University “La Sapienza”, Rome, Italy), a Ph.D. in Biomedical Engineering (Tufts University, Medford, MA), and a Research Fellowship at the A. Martinos Center for Biomedical Imaging, Department of Radiology of the Massachusetts General Hospital, Harvard Medical School. Prior to joining the FDA, Dr. Angelone has been a consultant with the Research and Development Department in the Surgical Products Division of Hologic Inc.
