GAUSH MEDITECH (02407): The eye electrophysiological examination system has obtained the Chinese medical device registration certificate.

GAUSH MEDITECH (02407) announced that its subsidiary Shenzhen Gaovision Technology Co., Ltd. (Gaovision) recently obtained a medical device registration certificate approved by the Guangdong Provincial Food and Drug Administration for its "Electroretinography System". The Electroretinography System approved this time by Gaovision (registration certificate number: Yuezhaizhun 20252161439) includes three main functions: Visual Evoked Potentials (VEP), Electroretinogram (ERG), and Electrooculogram (EOG). The VEP function is mainly used for the electroretinography of the optic nerve, evaluating the entire visual pathway function from the retinal ganglion cells to the visual cortex. For patients who cannot cooperate with subjective visual acuity testing, VEP can serve as an objective tool for monitoring brain function. In neurosurgical procedures, VEP can be used for real-time monitoring of the functional status of the optic nerve, optic chiasm, and optic tract, especially in pituitary region surgeries, to alert to potential vision loss due to surgical operations. The ERG function primarily evaluates retinal function (light sensitivity, bipolar cells, etc.), which can be used to screen for retinal diseases. The EOG is used to evaluate the function of the retinal pigment epithelium and photoreceptors and can help differentiate diseases such as retinal pigment degeneration. The Electroretinography System has become one of the routine examination methods in ophthalmology, providing a pathway for the examination and diagnosis of retinal diseases and offering an objective means of examining retinal function and optic nerve lesions. By extracting specific electrophysiological signals emitted by the human visual system in response to specific optical signal stimulation, this system enables accurate early positioning and diagnosis of ophthalmic diseases, suitable for detecting diseases of the visual pathway, optic nerve, and retina. This system's examination technology uses changes in bioelectricity during the visual formation process as an observation index, reflecting the functional status of the visual system at different levels from different perspectives. It has the characteristics of non-invasiveness, objectivity, quantification, and repeatability, and plays an important role in the diagnosis and differential diagnosis of ophthalmic diseases, evaluation of prognosis and therapeutic efficacy, and objective assessment of visual function.