Eye-tracking brain injury assessment device

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
21-04-2021

可用日期:

TBI diagnostics Pty Ltd

类:

Class IIa

厂商:

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

治疗领域:

65064 - Eye-tracking brain injury assessment device

疗效迹象:

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.

授权状态:

A

授权日期:

2021-04-19

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