Microclear Receives CE-MDR Certification for SKY Full-Eye Imaging Platform and Ultra-Widefield Laser Fundus Camera
Microclear Medical
Provider of Medical Imaging and Ophthalmic Diagnosis and Treatment Equipment
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Recently,Suzhou Microclear Medical Instruments Co., Ltd.(abbreviation: "Microclear Medical") two core ophthalmic imaging devices ——SKY Full-Eye Imaging Platform and Ultra-Widefield Laser Fundus Camera，Successfully Obtained EU CE-MDR Certification, marking an important step in its globalization strategy.
SKY Full-Eye Imaging Platform IntegrationCompletedFive-laser Path and Multiple Synchronized Imaging Modes，Supports synchronized scanning of SS-OCT and fundus imagingBy combining traditional image algorithms with artificial intelligence algorithms, the efficiency of image recognition and analysis has been significantly improved. The application of this technology not only enhances the accuracy of diagnosis but also provides abundant data support for ophthalmic research, particularly showing great potential in the study of retinal blood flow patterns and fundus diseases.
The breakthrough by Microclear Medical complements the technological innovations and market strategies of other ophthalmic imaging equipment manufacturers in China, such as the SLO ultra-widefield confocal fundus camera by Yaoshi Medical and the Ru Yi True Color Camera by Optoimaging, both of which have made a significant market impact in terms of technology and application.
# Product Technical Features
Real-time Synchronization of Multimodal Imaging
SKY Full-Eye Imaging Platform integrates Confocal Scanning Laser Ophthalmoscopy (CSLO) with Swept-Source Optical Coherence Tomography (SS-OCT) technology, supporting various fundus imaging modalities including ultra-widefield laser color photography, autofluorescence, Fluorescein Fundus Angiography (FFA), Indocyanine Green Angiography (ICGA), and OCT cross-sectional images.
Compared with traditional multi-modal imaging systems, the SKY platformCan simultaneously acquire multiple imaging data through a single scan., significantly improving the efficiency and accuracy of diagnosis.
Optical Zoom and Dynamic Video Preview
The SKY platform is equipped with uniqueLossless Optical Zoom Technology, which can provide real-time preview and recording, offering higher quality imaging data for ophthalmic diagnosis and treatment.
SystematicNon-mydriatic FunctionMaking patient examinations more convenient and effectively reducing discomfort during the examination process.
Ultra-Wide Angle and Ultra-Deep Imaging
Adoption of the SKY PlatformUltra-Wide Angle and Ultra-Deep ImagingTechnology has broken through the limitations of traditional ophthalmic imaging equipment in observing peripheral lesions, providing a better representation of the entire fundus and aiding clinicians in capturing hard-to-observe details.
SKY Full-Eye Imaging Platform integrates Confocal Scanning Laser Ophthalmoscopy (CSLO) with Swept-Source Optical Coherence Tomography (SS-OCT) technology, supporting various fundus imaging modalities including ultra-widefield laser color photography, autofluorescence, Fluorescein Fundus Angiography (FFA), Indocyanine Green Angiography (ICGA), and OCT cross-sectional images.
Compared with traditional multi-modal imaging systems, the SKY platformCan simultaneously acquire multiple imaging data through a single scan., significantly improving the efficiency and accuracy of diagnosis.
The SKY platform is equipped with uniqueLossless Optical Zoom Technology, which can provide real-time preview and recording, offering higher quality imaging data for ophthalmic diagnosis and treatment.
SystematicNon-mydriatic FunctionMaking patient examinations more convenient and effectively reducing discomfort during the examination process.
# Made in ChinaUltra-Widefield Fundus Camera Market
In tertiary hospitalsThe hardware design of the ultra-wide-angle fundus camera needs to meet the demands of complex cases.Using laser confocal technology can capture tiny changes in the peripheral retina with a resolution as high as 10μm, which helps assess the risk of retinal holes and identify deep microaneurysms in diabetic retinopathy.
Moreover, compared with non-laser devices, laser confocal devices perform better in handling deep lesions and complex refractive media. For instance, they can bypass lens opacity to provide clear images during preoperative cataract examinations, assisting in surgical evaluation.
In primary healthcare institutions, the design of ultra-widefield fundus cameras focuses more on ease of use and adaptability.The ergonomic design of the shell and one-touch reset focusing function enable even non-professionals to quickly get started. Moreover, its low-power design and dustproof structure ensure stable operation in harsh environments, facilitate maintenance, and guarantee the image quality for grassroots screening.
Suzhou Microclear Medical CRO Series: The first ultra-widefield confocal laser ophthalmic multimodal imaging system in China, launched in 2020, features a 5μm ultra-clear resolution and6 Shooting Modes, which can provide high-quality fundus images to assist in diagnosis. Microclear Medical Ru Yi True Color Camera: Global launch in 2025, single-shot imaging range up to 186°, true color area increased by 90%, maximum mosaic up to 280°, optical resolution exceeding 6.8μm, balancing true color, breadth, and clarity. Jiangsu Fuhan Medical CreoTone Ophthalmic Wide-field Imaging System Ultra: The world's first pediatric ophthalmic product equipped with a 160° ultra-wide-angle lens, featuring the smallest 7mm variable-focus lens currently available in the industry, capable of electronically switching between 90/130/160-degree fields of view. Microclear Medical Digital Fundus Camera DF600: High resolution, wide field of view, no distortion, full-layer retinal imaging based on confocal and weak laser technology, ultra-wide-angle high-resolution rapid imaging without pupil dilation. Bigewei Medical Technology BVF8000 Series: Approved for marketing in 2025, single-shot fundus imaging covers a 170-degree retinal range, with nine-image stitching reaching 260 degrees. It supports more than ten imaging modes and integrates an AI-assisted analysis system to improve diagnostic efficiency and accuracy.
Hardware Innovation and Development Space for Chinese-Made Products:
Independent R&D of Core Hardware Components: Including the optimization of laser light source modules and the domestic substitution of image sensors. Through technological breakthroughs, domestically produced equipment will make greater progress in image quality, stability, and cost-effectiveness.
Process Consistency Control: Improve the coating accuracy of optical components and the injection molding consistency of plastic parts to ensure the consistency and reliability of the equipment across different production batches.
Scenario-based Hardware Customization: To meet different market demands, such as grassroots screening and myopia prevention and control, customized hardware design will become an important direction for future development. Simplifying operations and lowering the usage threshold will further promote the popularity of equipment in the grassroots market.
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