Article preview from "The Gray Sheet"- September 4, 2012
FDA's device center is developing computational models of the human brain to help regulators and device designers assess the physiological effects of electromagnetic fields – such as those generated by implanted nerve stimulators – on the nervous system.
Article preview from "The Gray Sheet"- September 4, 2012
With contractor proposals in hand, FDA is poised to pick a computational model simulating the brain’s reaction to electromagnetic fields. The agency's device center expects the model to help pre-market reviewers quickly assess the safety and efficacy of implanted nerve stimulators, transcranial magnetic stimulators and magnetic resonance imaging devices.
The model should also prove useful to researchers and manufacturers, as the agency plans to make it available to the public.
FDA has an overarching goal to develop computational models of the human anatomy and physiology to predict how medical devices will perform. The idea is that the models can complement and in some cases go beyond bench, animal and clinical testing in a highly cost-effective way.
"For this specific project, the goal is to develop models based on data from human subjects and try to get a better understanding of the interactions between electromagnetic fields and the physiological human system," said Leonardo Angelone, a staff fellow in the Division of Physics at FDA's Office of Science and Engineering Laboratories (OSEL).
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