ZEISS Medical Technology has secured National Medical Products Administration (NMPA) approval for its CLARUS 700 ultra-widefield fundus imaging system in China, marking a significant regulatory milestone that expands access to advanced retinal diagnostics across the world’s largest healthcare market. The approval positions ZEISS to capture substantial market share in China’s rapidly growing ophthalmology sector, where diabetic retinopathy and age-related macular degeneration cases continue to surge.
The CLARUS 700 HD ultra-widefield fundus imaging camera delivers true color, high-resolution images, capturing 133° in a single image and up to 267° with multiple captures. This retinal imaging technology integrates fluorescein angiography with live infrared imaging capabilities, enabling comprehensive visualization from the macular region to the extreme retinal periphery. The system’s PrecisionFocus feature allows rapid detail identification, while QuickCompare functionality facilitates longitudinal pathology assessment.
“ZEISS CLARUS 700 represents a major step forward in retinal imaging,” emphasizes Anuj Kalra, Head of Chronic Disease Management at ZEISS Medical Technology, highlighting the system’s integration of ultra-widefield fluorescein angiography with true-color reproduction for enhanced diagnostic precision.
The NMPA approval addresses critical unmet needs in China’s ophthalmology market, where retinal imaging technology adoption has accelerated, driven by increasing diabetes prevalence and aging demographics. Maxwell Liu, Head of Sales & Services at ZEISS Medical Technology China, notes the CLARUS 700 “will provide unparalleled diagnostic precision for Chinese doctors and unprecedented comfort for their patients” through its AI-enhanced capture capabilities and improved workflow efficiency.
This approval follows ZEISS’s broader regulatory strategy of expanding its retinal imaging technology portfolio across key Asian markets. The CLARUS 700’s NMPA clearance leverages clinical evidence demonstrating superior early diabetic retinopathy assessment compared to conventional imaging modalities. With Carl Zeiss Meditec AG generating €2.066 billion in fiscal 2023/24 revenue, the China expansion represents a strategic growth catalyst in the competitive ophthalmology diagnostics landscape.
The approval positions ZEISS to capitalize on China’s healthcare digitization initiatives while reinforcing its competitive advantage in ultra-widefield retinal imaging technology against established players in the diagnostic imaging sector.
ZEISS CLARUS 700 for advanced Retinal Imaging technology
