Medical Devices

Neurological Devices

Contact

Srikanth Vasudevan, Ph.D.
Meijun Ye, Ph.D.

Peripheral Nerve Research

Comprehensive assessment of the safety and efficacy of peripheral nerve implant technologies for neuroprosthetic and neuromodulation applications.

Brain Interface Research

We investigate the electrode/tissue interface, using chronic in vivo electrophysiology to assess device performance, immunohistochemistry and advanced tissue processing technology (CLARITY) to evaluate neural structure and neuroinflammation, longitudinal in vivo imaging to look at structural dynamics of neurons and vasculature, and in vitro assays to detect changes to electrode materials properties.

Traumatic Brain Injury Research

We use high intensity focused ultrasound to induce mild traumatic brain injury (mTBI) in mouse, histological and behavioral testing to evaluate structural damage and functional deficit following mTBI, and in vivo electrophysiology and imaging techniques to detect mTBI. We investigate the use of novel EEG electrodes for the detection of mTBI. 

Summary

Medical devices that interface directly with the human nervous system are emerging as essential therapeutic and diagnostic modalities for conditions including paralysis, amputation, Parkinson’s disease, epilepsy and rheumatoid arthritis. Novel neurotechnologies, such as those under development in the BRAIN initiative, NIH SPARC, and the DARPA HAPTIX and ElectRx programs, have the potential to expand the impact of device interventions to improve patient health. Using cutting-edge research methodology and state-of-the-art technology, our laboratory investigates the safety and reliability of neurological devices applicable to the central and peripheral nervous systems. Continued investment in regulatory science projects involving innovative medical device technology lays the framework for more rapid, science-based regulatory device review at the FDA.

Central Nervous System Research led by Meijun Ye, Ph.D.

  • Assessment of the long-term reliability of implanted electrodes
  • Characterization of acute and long-term neural tissue and functional responses to implanted neural devices
  • Evaluation of long-term reliability of optogenetic stimulation methods
  • Identification of electrophysiological biomarkers of neural damage induced by electrical stimulation
  • Development of an ultrasound induced traumatic brain injury model in rodents
  • Investigation of emerging technologies for the diagnosis of mild traumatic brain injury in rodent models
  • Translational investigation of novel diagnostic biomarkers for mild traumatic brain injury in a patient population

Peripheral Nervous System Research led by Srikanth Vasudevan, Ph.D.

  • Development of chronic animal model to evaluate peripheral nerve interfaces
  • Evaluation of the safety of ultrasound for neuromodulation
  • Assessment of novel ultrasound powered implants for power transfer and telemetry
  • Identification of the effects of sex difference in the safety of autonomic (vagus) nerve stimulation for neuromodulation.

Current funding sources

FDA Medical Countermeasures Initiative (MCMi)

Office of the Chief Scientist Challenge Grant

FDA Critical Path Initiative

Defense Advanced Research Projects Agency (DARPA)

Personnel

FDA Staff:
Srikanth Vasudevan, Ph.D.
Meijun Ye, Ph.D.
Daniel X. Hammer. Ph.D.
Krystyna Solarana, Ph.D.

Visiting Scientists
Eugene F. Civillico, Ph.D.

Research Fellows:
Sepideh Asgari
Harmain Rafi
Hyounguk Jang, Ph.D.
Kee Jang, Ph.D
Benjamin Shafer
Farid Yaghouby, Ph.D.
Elissa Wong, Ph.D.
Jesse Vo 

FDA collaborators

Luann McKinney, Ph.D.
Leslie McKinney, Ph.D.
Matthew Myers, Ph.D.
Shyama Patel, Ph.D.
Joshua Pfefer, Ph.D.
Jakob Reister, Ph.D.
Larry Schmued, Ph.D
Christopher Scully, Ph.D.
Pavel Takmakov, Ph.D.
Christopher Toscano, Ph.D.
Lin Xu , M.D., Ph.D.
 

External collaborators

DARPA Biological Technologies Office
University of California, San Diegodisclaimer icon
University of Utahdisclaimer icon
University of California Berkeleydisclaimer icon
Stanford Universitydisclaimer icon
Uniformed Services University of the Health Sciencesdisclaimer icon
Walter Reed National Military Medical Center
New York Medical Collegedisclaimer icon
University of Colorado Denverdisclaimer icon

Resource facilities

Neurological Devices Laboratory

  • State-of-the-art small animal surgical suite
  • Broadband impedance measurement system
  • Electrophysiological recording, stimulation and analysis system
  • Video based behavioral assessment systems
  • Two-photon microscope
  • Optical coherence tomography
  • Olympus confocal microscope

Additional resources

Public Workshop on Brain-Computer Interface Devices for Patients with Paralysis and Amputation

Public Workshop – Advancing the Development of Biomarkers in Traumatic Brain Injury

Relevant standards & guidances

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

Page Last Updated: 05/31/2018
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