About FDA

Laboratory of Biophysics

Laboratory leader: Sunder Rajan 301.796.4194 Sunder.Rajan@fda.hhs.gov

The Biophysics laboratory program centers on the studying the interactions of stimulating medical devices and imaging technologies with the body. This program covers a wide range of medical device areas including those used for  stimulating the brain, retina, cochlea, spinal cord, peripheral nerves, and the cardiovascular system.  The program also includes imaging devices such as magnetic resonance imaging. The research program is specifically aimed at understanding the basic mechanisms of these devices, their efficacy, fields generated, resolution capabilities, long-term effects, and their safe levels of use in humans. 

The Biophysics laboratory research projects focus on understanding current medical device issues found in the clinic as well as future technologies destined for clinical trials. These research projects help form a scientific basis for regulatory decisions, generate guidance documents for trial design, set industry standards, and determine safe levels of use. The Cardiovascular Device research projects study the optimization of waveforms of defibrillating electric pulses in relation to the heart’s mechanical cycle, gender-related differences in heart failure, and visualizing arrhythmia propagation mechanisms across cardiac tissue.

The Magnetic Resonance Imaging (MRI) research project aims to validate the performance of new MRI technologies that have the potential to serve as biomarkers for brain, cardiovascular, and whole body function.

The Peripheral Nerve Implant stimulation research project evaluates the safety and effectiveness of novel stimulation technologies, develops biomarkers for neurotoxicity, and studies the effects of implant stretch and injury. Finally, the Retinal Prostheses research project focuses on optimizing stimulation of the visually impaired retina,  developing better methodologies for determining safe levels of retinal stimulation, and evaluating novel vision therapies for the blind.

Page Last Updated: 11/03/2014
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