Eye-tracking brain injury assessment device

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Доступно од:

TBI diagnostics Pty Ltd

Класа:

Class IIa

Произведен од:

Oculogia Inc 33 Irving Place, New York, New York, 10003 United States Of America

Терапеутска област:

65064 - Eye-tracking brain injury assessment device

Терапеутске индикације:

The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Статус ауторизације:

A

Датум одобрења:

2021-04-19