Core Viewpoint - The announcement highlights that Gaoshi Medical's subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has received approval for its "Electrophysiological Examination System" from the Guangdong Provincial Drug Administration, marking a significant advancement in ophthalmic diagnostic tools [1][2]. Group 1: Product Features - The approved system includes three main functions: Visual Evoked Potential (VEP), Electroretinography (ERG), and Electrooculography (EOG) [1]. - VEP is primarily used for assessing the visual pathway function from the retinal ganglion cells to the visual cortex, serving as an objective monitoring tool for patients unable to cooperate with subjective vision tests [1]. - ERG evaluates retinal function, particularly in detecting retinal diseases, while EOG assesses the function of the retinal pigment epithelium and photoreceptors, aiding in the differentiation of diseases like retinitis pigmentosa [1]. Group 2: Clinical Applications - The Electrophysiological Examination System has become a routine examination method in ophthalmology, providing pathways for the diagnosis of fundus diseases and objective examination methods for retinal function and optic nerve lesions [2]. - The system's technology extracts specific electrophysiological signals from the visual system in response to optical stimuli, enabling accurate early diagnosis of ocular diseases [2]. - Its non-invasive, objective, quantitative, and repeatable characteristics make it significant for diagnosing and differentiating diseases, evaluating treatment efficacy, and objectively assessing visual function [2].
高视医疗：眼电生理检查系统获得中国医疗器械注册证