Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF AUGUST 08, 2021 SAM #7190
SOLICITATION NOTICE

66 -- EEG System

Notice Date

8/6/2021 7:00:03 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

75F40121Q00110
 

Response Due

8/17/2021 7:00:00 AM
 

Archive Date

09/01/2021
 

Point of Contact

Brian Wodzisz, Phone: 301-796-7376
 

E-Mail Address

brian.wodzisz@fda.hhs.gov
(brian.wodzisz@fda.hhs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

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
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/51d2b4d8fd774e348378b92d7b36714b/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN06088563-F 20210808/210806230123 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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