NIH BRAIN Initiative Workshop: Industry Partnerships to Facilitate Early Access to Neuromodulation and Recording Devices for Human Clinical Studies

The purpose of the conference is to address the compelling need for a streamlined path for developing and integrating innovative new technologies for human brain research. It will familiarize clinical and industry investigators with device capabilities that may be enabled through Investigational Device Exemption (IDE) and provide academic investigators with potential complementary opportunities that may be available through clinical investigators. This meeting will help foster future collaborations in which industry partners would provide academic scientists with general technological support for use, clinical/pre-clinical data on safety/utility with some companies providing free devices, complementary/supplemental data, and fMRI data of circuitry affected by implants. It will provide a forum for bi-directional discussion of terms outlined in the preliminary Memorandum of Understanding (MOU), including intellectual property and terms of data availability. This workshop will also allow interaction between the FDA, clinical investigators, academic investigators, and industry partners to discuss regulatory hurdles.Air date: 6/3/2015 8:00:00 AM
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