GAUSH MEDITECH (02407) announced that its subsidiary, Shenzhen Gaush Technology Co., Ltd., has recently obtained a medical device registration certificate from the Guangdong Provincial Medical Products Administration for its "Ophthalmic Electrophysiological Examination System."
The newly approved system (Registration Certificate No.: Yue Xie Zhun 20252161439) integrates three primary functions: Visual Evoked Potential (VEP), Electroretinogram (ERG), and Electrooculogram (EOG).
The VEP function is primarily used for electrophysiological examination of the optic nerve, enabling direct assessment of the entire visual pathway from retinal ganglion cells to the visual cortex. It serves as an objective brain function monitoring tool for patients unable to undergo subjective vision tests. In neurosurgery, VEP can monitor the functional status of the optic nerve, optic chiasm, and optic tract in real time—particularly during sellar region surgeries (e.g., pituitary adenoma, craniopharyngioma)—to warn of potential vision impairment caused by surgical procedures.
The ERG function evaluates retinal function (photoreceptors, bipolar cells, etc.) and aids in screening for retinal diseases. Meanwhile, the EOG assesses retinal pigment epithelium and photoreceptor function, assisting in diagnosing conditions such as retinitis pigmentosa.
As a routine ophthalmic examination tool, the system provides diagnostic pathways for fundus diseases and offers objective evaluation methods for retinal function and optic neuropathy. By extracting specific electrophysiological signals from the visual system under controlled optical stimulation, it enables precise early-stage localization of ophthalmic diseases, applicable to detecting disorders of the visual pathway, optic nerve, and retina.
The system measures bioelectrical changes during visual formation, reflecting functional states across different levels of the visual system. Its non-invasive, objective, quantitative, and repeatable characteristics make it invaluable for diagnosis, differential diagnosis, prognosis evaluation, and objective assessment of visual function in ophthalmic diseases.