Long-term Safety and Performance of Peripheral Nerve Devices for Neuroprosthetics and Neuromodulation

Abstract: In this talk, Dr. Srikanth Vasudevan will give an overview of on-going regulatory science efforts in the Neurological Devices Lab, focused on supporting the development of safe and effective devices that interact with the peripheral nervous system. This includes peripheral nerve interfaces (PNI) and neuromodulation devices. PNIs are medical devices that serve as a bridge between peripheral nerves and external components, such as a computer, or a neuro-prosthetic device. These devices are capable of sensing nerve impulses, as well as sending information to the nerves from external devices through stimulation. PNIs are currently being studied for restoring motor and sensory function in amputees using neuro-prosthetic devices. Neuromodulation devices deliver targeted stimuli to peripheral nerves for modulating the function of its targets. Neuromodulation through autonomic nerve stimulation is approved for the treatment of epilepsy, depression, and cluster headache. Areas of on-going neuromodulation research includes the treatment of rheumatoid arthritis, type II diabetes, polycystic ovary syndrome, post-traumatic stress disorder and, tinnitus. FDA’s readiness to regulate next generation PNI technologies and neuromodulation devices will provide patients with expedited access to safe and effective medical devices first in the world.

Bio: Dr. Srikanth Vasudevan received his M.S. and Ph.D. in Biomedical Engineering from the University of Texas at Arlington and the University of Texas Southwestern Medical Center joint program. He joined the U.S. Food and Drug Administration in 2014 and works in the field of peripheral nerve devices for neuroprosthetics and neuromodulation. His research is funded by the National Institutes of Health, Defense Advanced Research Projects Agency, and the Division of Biomedical Physics. Dr. Vasudevan is a recipient of several awards, including one for the development of novel biomarkers for peripheral nerve injury.