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Biosensor to Stimulate Nerve. Evidence shows that, under certain conditions, electrical neurostimulation can cause the release of harmful levels of neuroactive substances from the axons of nerves. FDA is developing a simple neurochemical release assay that can selectively detect neurotransmitters by using conventional eletrophysiological techniques in conjunction with specialized biosensor probes. Our research will address the unmet need to establish neurochemical biomarkers for evaluating electrical stimulation parameters in normal, diseased and damaged nerves. The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health. CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective. February, 2011.
