The purpose of this procurement is to purchase an EEG System to be used with a VR headset in a research study to evaluate the performance of novel digital technologies in the diagnosis and treatment of neurological injuries or dysfunctional conditions. This procurement is only for the purchase of an EEG System. The actual study is NOT part of the procurement request.

The EEG System we are looking to purchase will be used on human subjects with neural injuries or dysfunctional conditions, including chronic pain, traumatic brain injury, and Parkinson's disease. The FDA is looking to use the EEG System in combination with a VR headset in a research study to evaluate the performance of novel digital technologies in the diagnosis and treatment of neurological injuries or dysfunctions conditions.

CDRH/FDA has recently received and cleared multiple physiological monitoring devices as assessment aids for the detection of brain dysfunction. However, none of them have been used as a standalone diagnostic tool for TBI. Currently marketed technologies rely on a single physiological readout, which may limit their sensitivity. As TBI is highly diverse in injury location, nature of trauma, and pathophysiological pathways, we hypothesize that a multi-modal bio-sensing approach utilizing VR content will lead to order-of-magnitude gains in TBI detection sensitivity.

**See attachment Combined_SynSol_1243553.pdf for full Snyopsis/Solicitation details