In News

April 9, 2019

Devices for the Assessment of Head Injury

CDRH recognizes that head injury is a major source of concern since the presence and severity of a head injury may not be readily assessable. CDRH is committed to working with device researchers and developers to bring safe and effective devices to patients in the US that facilitate the assessment of head injury. The following table highlights medical devices available in the United States that are legally marketed. For more specific descriptions of these devices, their indications for use, and related information, please follow the links to the Premarket Databases shown.

Manufacturer Device Premarket Database (FDA Decision Date)
Banyan BTI* Brain Trauma Assessment Kit DEN170045 (2/14/2018)
BrainScope Company, Inc. BrainScope Ahead 100 DEN140025 (11/17/2014)
Ahead 200 K143643 (5/15/2015)
Ahead 300 K161068 (9/22/2016)
BrainScope One K181179 (5/18/2018)
Modified BrainScope One K181785 (12/19/2018)
ImPACT Applications, Inc ImPACT DEN150037 (8/22/2016)
K170209 (2/23/2017)
ImPACT Quick Test K170551 (6/21/2017)
InfraScan Infrascanner Model 1000 DEN100002 (12/13/2011)
Infrascanner K120949 (1/11/2013)
Oculogica, Inc. EyeBOX DEN170091 (12/28/2018)

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/NeurologicalDevices/ucm610799.htm

FDA: The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication
JAMA: Eye-Tracking Test Approved to Help Diagnose Concussion