COSMIIC System
Description
The COSMIIC System is a fully implantable neuromodulation platform now available for use in fundamental neuroscience, preclinical animal, and early-feasibility human research. Based on the Networked Neuroprosthetic (NNP) System invented at Case Western Reserve University, the platform was released to the community through NIH SPARC funding. The open-source scope covers all elements needed for benchtop, preclinical, and human use, including implantable hardware, firmware/software, mechanical components, test documentation, and regulatory documentation. The system has been used in human participants under FDA Investigational Device Exemptions and the ability to reference this existing work greatly reduces barriers to new development in the field of neuromodulation. Disclaimer: The COSMIIC System is for research use only, it is not a marketed medical device, and it is only for use in studies that have the appropriate institutional and regulatory approvals.
Version
beta
Risk class
Class IIa
State of development
Research
Project Type
Keywords
implant, device, Open Source, NNP, Network, Neuroprosthesis, Networked Neuroprosthetic, Power module, Pulse generator, biopotential recording, CAN, module, system, implant, implantable system, modular platform, COSMIIC, Cleveland, intramuscular stimulator
Intended use case
This device is intended for research use only in the field of neuromodulation. While the device has previously been manufactured to high-quality standards and is approved under an FDA IDE for specific early-feasibility study, it is not certified for general implantation or use in humans. Researchers must obtain their own regulatory approvals to use this device in human studies. Your personal decision to use of these devices is strictly your responsibility and at your own risk.
Licenses
Hardware
CERN-OHL-P-2.0
Software
MIT
Documentation
CC-BY-SA-4.0