Medical Devices

Neurological Devices

Contact

Krystyna Solarana, Ph.D.
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 nervous system are emerging as essential therapeutic and diagnostic modalities for conditions including paralysis, amputation, Parkinson’s disease, epilepsy, traumatic brain injury, rheumatoid arthritis, and blindness. Novel neurological devices, such as those under development in the BRAIN initiative, NIH SPARC, and the DARPA Biological Technologies Office, 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. Investment in regulatory science involving innovative medical device technologies advances science-based regulatory review at the FDA to ensure patients have expedited access to safe and effective neurological devices.

Central Nervous System Research led by Meijun Ye, PhD and Krystyna Solarana, PhD

  • Assessment of the long-term reliability of implanted electrodes
  • Characterization of acute and long-term neural tissue and functional responses to implanted passive and active neural devices
  • Evaluation of long-term safety and reliability of optogenetics
  • Investigation of emerging technologies for the diagnosis of mild traumatic brain injury in rodent models
  • Translating novel non-invasive diagnostic biomarkers of mild traumatic brain injury to a patient population

Peripheral Nervous System Research led by Srikanth Vasudevan, PhD

  • Development of test platforms to assess chronic safety and performance of peripheral nerve interfaces
  • Evaluation of the safety and efficacy of ultrasound for neuromodulation
  • Assessment of novel ultrasound powered implants for power transfer and telemetry
  • Identification of biological sex differences in the safety of autonomic neuromodulation
  • Development of predictive imaging biomarkers for electrical stimulation induced nerve injury

Funding sources

FDA Medical Countermeasures Initiative (MCMi)

Office of the Chief Scientist Challenge Grant

FDA Critical Path Initiative

Defense Advanced Research Projects Agency (DARPA)

NIH SPARC

Personnel

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

Visiting Scientists
Eugene F. Civillico, Ph.D.

Research Fellows:
Uyen Hoang
Hyounguk Jang, Ph.D.
Kee Jang, Ph.D.
Guillermo Monroy, Ph.D.
Harmain Rafi
Nicolas Vivaldi, Ph.D.
Elissa Wong, Ph.D.
Farid Yaghouby, Ph.D.

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

University of California, San Diegodisclaimer icon
University of Utahdisclaimer icon
Stanford Universitydisclaimer icon
Massachusetts General Hospitaldisclaimer 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
  • Wireless physiological monitoring system

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

Selected peer-review publications

Page Last Updated: 09/27/2018
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