Core Viewpoint - The approval of the "Electrophysiological Examination System" by the Guangdong Provincial Drug Administration marks a significant advancement for the company in the ophthalmology medical device sector, enhancing diagnostic capabilities for eye diseases [1][2]. Company Summary - The company's subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has received a medical device registration certificate for its electrophysiological examination system, which includes three main functions: Visual Evoked Potential (VEP), Electroretinography (ERG), and Electrooculography (EOG) [1]. - The VEP function is particularly useful for assessing the visual pathway from the retina to the visual cortex, serving as an objective monitoring tool for brain function in patients unable to cooperate with subjective vision tests [1]. - The ERG function evaluates retinal function and can be used to screen for retinal diseases, while the EOG assesses the function of the retinal pigment epithelium and photoreceptors, aiding in the differentiation of diseases like retinitis pigmentosa [1]. Industry Summary - The electrophysiological examination system has become a routine examination method in ophthalmology, providing pathways for the diagnosis of fundus diseases and offering objective examination methods for retinal function and optic nerve lesions [2]. - This system operates by extracting specific electrophysiological signals emitted by the visual system in response to optical stimuli, enabling accurate early diagnosis of eye diseases [2]. - The technology is characterized by its non-invasive, objective, quantitative, and repeatable nature, playing a crucial role in the diagnosis, differential diagnosis, and prognosis evaluation of eye diseases [2].
高视医疗(02407)：眼电生理检查系统获得中国医疗器械注册证