BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Funds taking a brain recording or stimulation device from prototype through safety testing and an FDA exemption into a first small clinical study.
This is the translational stretch of the BRAIN Initiative's device programme — the part between a device that works in a laboratory and a device that has been used in a person.
The funded activities are named: implementing clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation, obtaining an Investigational Device Exemption for a Significant Risk s…
Translational development of therapeutic and diagnostic devices for disorders of the nervous and neuromuscular systems — clinical prototype implementation, non-clinical safety and efficacy testing, design verification and validation, obtaining an Investigational Device Exemption for a Significant Risk study, and a subsequent small clinical study.
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