Recently, Suzhou Microclear Medical Instruments Co., Ltd. (Microclear Medical) announced that two of its flagship ophthalmic imaging devices—the SKY Full-Eye Imaging Platform and the Ultra-Widefield Laser Fundus Camera—have successfully received CE-MDR certification. This marks a significant milestone in the company’s global expansion strategy.

Technology Highlights

SKY Full-Eye Imaging Platform

The SKY platform integrates five laser channels and supports multiple synchronous imaging modes, enabling simultaneous SS-OCT and fundus imaging. By combining traditional image processing with AI-based algorithms, the system improves image recognition and analysis efficiency. This dual approach enhances diagnostic accuracy and provides rich data resources for ophthalmic research, particularly in studies of photoreceptor blood flow and retinal disease progression.

Key features include:

• Multimodal real-time imaging: Supports CSLO, SS-OCT, ultra-widefield color, fundus autofluorescence, fluorescein angiography (FFA), indocyanine green angiography (ICGA), and cross-sectional OCT.

• Non-invasive patient experience: A non-mydriatic system reduces patient discomfort during examination.

• Ultra-widefield & ultra-deep imaging: Enables clinicians to capture peripheral lesions and subtle details not easily detected with conventional devices.

• Optical zoom with dynamic preview: Provides real-time preview and recording with high image quality.

Ultra-Widefield Laser Fundus Camera

The CE-approved ultra-widefield fundus camera is designed for both advanced hospitals and broader screening programs. Its high-resolution laser confocal imaging (10 μm) allows clinicians to capture subtle retinal changes, assess retinal tear risks, and identify deep microaneurysms in diabetic retinopathy. Compared with non-laser systems, laser confocal devices also offer superior imaging performance in cases with complex refractive media, such as pre-cataract surgery assessments.

Industry Context and Innovation Potential

The CE-MDR certification highlights the increasing competitiveness of Chinese manufacturers in ophthalmic imaging. While China domestic products have made progress in ergonomic design, ease of use, and adaptability for primary care, challenges remain in high-precision optical components, image sensors, and laser source stability. Addressing these areas will be key to reaching global benchmark levels.

Future development directions include:

• Core hardware innovation: Localization of laser modules and imaging sensors.

• Process quality control: Improved consistency in optical coatings and injection molding.

• Scenario-driven customization: Tailored designs for different use cases, such as community screening or myopia prevention.

Company Overview

Founded in 2011 in Suzhou Industrial Park, Microclear Medical specializes in advanced ophthalmic imaging solutions, integrating proprietary hardware with AI and connectivity technologies. Its portfolio includes ultra-widefield confocal fundus cameras, confocal angiography systems, and handheld digital slit lamps, covering diagnosis, screening, and research applications.

Microclear Medical was the first China domestic company to apply ultra-widefield confocal laser technology to ophthalmic imaging, breaking long-standing foreign monopolies. Today, its products are used in over 300 hospitals in China, including leading institutions such as Zhongshan Ophthalmic Center and Peking Union Medical College Hospital, and are exported to more than 30 countries and regions worldwide.

Sep 16, 2025, MedChina