Sep 20, 2017
12:00 PM



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.


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.


Sep 27, 2017
12:00 PM




There is currently no available technology to directly record neural activity from
the entire volume of the brain. Bioengineering efforts have propelled electrode-based
devices and optical probes, achieving nanometer scale spatial resolution and impressive
signal-to- noise ratio and temporal response; however, these techniques are invasive and
sample from very small areas in the nervous system. On the other hand, modalities such
as functional MRI (fMRI) can generate a volumetric readout from the entire brain
noninvasively, and with relatively good temporal resolution, but usually provide
information more directly related to blood flow and metabolism rather than direct
electrical or chemical neural signaling. Overcoming these shortcomings, and developing
sensing modalities for whole-brain direct recording of neural signals, will allow
neuroscientists and neurologists to study the brain network directly and as a whole—an
achievement that will surely elevate neuroscience, neurology and medicine to new
heights. I will present my research involving the development and application of injectible 
molecular probes and nanofabricated components for neuroimaging using fMRI. I will
describe recent unprecedented in-vivo fMRI measurements of cellular neurotransmitter
uptake using a specialized sensor, as well as the development of nanofabricated
electromagnetic sensors based on neuron-device interfacing for multi-site recording of
neuronal intracellular signals. These strategies enable us for the first time to perform
functional studies of neural activity across wide brain regions with molecular and
electrophysiological specificity, and pave the way towards developing novel nano-scale
sensing components for minimally-invasive whole brain recording of neural activity.
About the Speaker:

Dr. Aviad Hai is a neuroengineer and a neuroscientist with extensive expertise
and highly cited scientific contributions to the field of nanometer-scale probes for brain
imaging and recording. In his postdoctoral research at the Massachusetts Institute of
Technology, Dr. Hai headed a team that has made unprecedented in-vivo fMRI
measurements of cellular uptake of the neurotransmitter serotonin, using a specialized
sensor (Hai et al., 2016, Neuron). Together with his work on nanofabricated devices for
on-chip multi-site recording of neuronal intracellular signals (Hai et al., 2010, Nat
Methods, for review see: Spira & Hai, 2013, Nat Nanotechnology), Dr. Hai is shaping his
scientific strategy toward developing and applying novel sensors for whole-brain
recording, and guiding future researchers in cutting-edge technologies for the detection
of neural activity. Dr. Hai has won numerous awards and fellowships, and his work is
supported by the National Institutes of Health (NIH), the European Molecular Biology
Organization (EMBO) and the Edmond & Lily Safra Center for Brain Sciences (ELSC).