GAUSH MEDITECH: The corneal confocal microscope has obtained the national medical device registration certificate

Zhitong
2025.04.09 11:11
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GAUSH MEDITECH announced that its wholly-owned subsidiary GAUSH Innovation Technology Co., Ltd. has obtained the medical device registration certificate from the Jiangsu Provincial Drug Administration for the corneal confocal microscope T3-600 and T3-400. This microscope is the first device in China that combines a wide field of view with high resolution, utilizing laser light sources and optical coherence tomography scanning technology, significantly improving imaging quality and assisting in the diagnosis of various corneal and conjunctival diseases. GAUSH Innovation also plans to add AI features to the product to enhance diagnostic efficiency and accuracy

According to the announcement from GAUSH MEDITECH (02407), its wholly-owned subsidiary GAUSH Innovation Technology Co., Ltd. ("GAUSH Innovation") has recently obtained the medical device registration certificate approved by the Jiangsu Provincial Drug Administration for its independently developed corneal confocal microscopes, model T3-600 and T3-400.

This corneal confocal microscope has achieved industry breakthroughs through technological innovation, becoming the first of its kind in China to combine a wide field of view with high resolution. The device uses laser light sources and tomographic confocal scanning technology, enhancing the scanning field to 600×600μm, with an optical resolution of 1.1μm and a digital resolution of 0.4μm, significantly improving imaging quality. The corneal confocal microscope can observe the cornea and conjunctiva in vivo, assisting in the diagnosis of various corneal and conjunctival diseases: infectious diseases, non-infectious diseases including corneal degeneration, dystrophy, immune lesions, keratoconus, as well as surgery-related, trauma, dry eye, and systemic disease-related corneal lesions, providing a basis for disease diagnosis and condition assessment.

GAUSH Innovation has planned AI functionality expansion paths for the T3 products, and will subsequently implement features such as automatic image analysis through AI to enhance diagnostic efficiency and accuracy. Meanwhile, the T3 products have also initiated the CE registration process