FDA Perspectives on the Regulation of Neuromodulation Devices.

The United States Food and Drug Administration (FDA) ensures that patients in the United States have access to safe and effective medical devices. The division of neurological and physical medicine devices reviews medical technologies that interface with the nervous system, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices.

Structure, Function, and Propagation of Information across Living Two, Four, and Eight Node Degree Topologies.

In this study, we created four network topologies composed of living cortical neurons and compared resultant structural-functional dynamics including the nature and quality of information transmission. Each living network was composed of living cortical neurons and were created using microstamping of adhesion promoting molecules and each was "designed" with different levels of convergence embedded within each structure. Networks were cultured over a grid of electrodes that permitted detailed measurements of neural activity at each node in the network.

Scale of Carbon Nanomaterials Affects Neural Outgrowth and Adhesion.

Carbon nanomaterials have become increasingly popular microelectrode materials for neuroscience applications. Here we study how the scale of carbon nanotubes and carbon nanofibers affect neural viability, outgrowth, and adhesion. Carbon nanotubes were deposited on glass coverslips via a layer-by-layer method with polyethylenimine (PEI).

An in vitro method to manipulate the direction and functional strength between neural populations.

We report the design and application of a Micro Electro Mechanical Systems (MEMs) device that permits investigators to create arbitrary network topologies. With this device investigators can manipulate the degree of functional connectivity among distinct neural populations by systematically altering their geometric connectivity in vitro. Each polydimethylsilxane (PDMS) device was cast from molds and consisted of two wells each containing a small neural population of dissociated rat cortical neurons.

Large extracellular spikes recordable from axons in microtunnels.

When extracellular action potentials (spikes) from cultured neurons are recorded using microelectrode arrays in open wells, their amplitudes are usually quite small (often below the noise level) despite the extracellular currents originating from the relatively large surface area of neural cell somata. In this paper rat cortical neurons were seeded into one well of a two well system separated by 3 × 10 μm microtunnels and then seven days later into the second well forming a feed-forward network between two small neuronal assemblies. In contrast to measurements in the open well spikes recorded from axons within the restricted volumes imposed by the microtunnels are often several orders of magnitude larger than in the open well, with high signal to noise ratio, despite the currents originating in the much smaller surface area of the axon.

Propagation of action potential activity in a predefined microtunnel neural network.

A polydimethylsiloxane microtunnel device with two wells is aligned and attached on top of a multi-electrode array. Neurons are grown first in one well and allow the propagation of axons through the tunnels into a second well. After 10 days, cells are plated in the second well, with much lower likelihood of extending axons back to the first well, with the intent of creating unidirectional connectivity between populations of neurons in the two wells.