ZEISS CLARUS 700 Receives NMPA Approval in China

Rhea-AI Summary

ZEISS Medical Technology has received NMPA approval in China for its CLARUS 700 fundus imaging device, marking a significant advancement in retinal diagnostics. The device offers ultra-widefield, high-resolution imaging with True Color capabilities and Fluorescein Angiography functionality. The CLARUS 700 captures 133° in a single image and up to 267° with multiple captures, providing comprehensive visualization from the macula to the peripheral retina. Key features include PrecisionFocus for detailed region viewing, QuickCompare for pathology monitoring, and AutoBright for efficient image analysis. The device aims to enhance diagnostic precision and patient comfort in the Chinese market while supporting improved patient vision preservation through advanced retinal workflow integration.

Positive

• NMPA approval opens access to the large Chinese healthcare market
• Advanced imaging capabilities with 133° single capture and up to 267° multiple capture coverage
• Integration of multiple technologies including True Color, Fluorescein Angiography, and live infrared imaging
• Enhanced workflow efficiency through AI-enhanced capture and automated features

Negative

• None.

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ZEISS Medical Technology expands retinal insights for ophthalmologists with ultra-widefield, high-resolution imaging capabilities

JENA, Germany and SHANGHAI, June 5, 2025 /PRNewswire/ -- ZEISS Medical Technology announced today that the CLARUS^® 700 from ZEISS has received National Medical Products Administration (NMPA) approval in China, offering advanced retinal diagnostic capabilities with ultra-widefield, high-resolution images in True Color and unsurpassed quality. The fundus imaging device with Fluorescein Angiography helps eye care specialists in China unlock the full potential of their clinic's retina workflow to support improved patient vision preservation. 

"ZEISS CLARUS 700 represents a major step forward in retinal imaging," emphasizes Anuj Kalra, Head of Chronic Disease Management at ZEISS Medical Technology. "By seamlessly integrating ultra-widefield Fluorescein Angiography (FA) imaging with true-color reproduction, this system delivers unprecedented clarity for comprehensive visualization from the macular region to the extreme retinal periphery, enhancing efficiency and supporting precise decision-making within the ZEISS Retina Workflow."

"Integrating ultra-widefield imaging, unsurpassed clarity, and AI-enhanced capture, the CLARUS 700 redefines fundus angiography benchmarks. It will provide unparalleled diagnostic precision for Chinese doctors and unprecedented comfort for their patients," says Maxwell Liu, Head of Sales & Services at ZEISS Medical Technology China.

Ultra-widefield fluorescein angiography serves as a highly valuable examination tool for assessing nonperfused retinal areas. The ZEISS CLARUS 700 HD ultra-widefield fundus imaging camera is an advanced retinal imaging system that provides True Color, high-resolution images. It captures 133°¹ in a single image and up to 267° with multiple captures, offering detailed views of the retina. Equipped with both fluorescein angiography and live infrared imaging capabilities, the CLARUS 700 aids in diagnosing and monitoring retinal diseases².  Furthermore, the fundus imaging camera offers innovative technology features including PrecisionFocus for quickly seeing details in the regions of interest, QuickCompare to compare pathology changes observed in past patient visits, and AutoBright so ophthalmologists can spend more time analyzing images and less time adjusting them. 

More information about the CLARUS^® 700 from ZEISS can be found here.

¹ CLARUS 700#white-paper
² Xiao, Y., Dan, H., Du, X. et al. Assessment of early diabetic retinopathy severity using ultra-widefield Clarus versus conventional five-field and ultra-widefield Optos fundus imaging. Sci Rep 13, 17131 (2023). https://doi.org/10.1038/s41598-023-43947-5

Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development. The statements of the healthcare professionals reflect only their personal opinions and experiences and do not necessarily reflect the opinion of any institution that they are affiliated with. The healthcare professionals alone are responsible for the content of their experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates to not have clinical evidence supporting the opinions and statements of the health care professionals nor accept any responsibility or liability of the healthcare professionals' content. The healthcare professionals have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support. 

Contact for investors
Sebastian Frericks
Director Investor Relations
Carl Zeiss Meditec AG
Phone: +49 3641 220 116
Mail: investors.med@zeiss.com

Contact for the press
Frank Smith
Head of Global Communications Ophthalmology
Carl Zeiss Meditec Inc.
Phone: +49 3641 220 331
Mail: press.med@zeiss.com

www.zeiss.com/newsroom

Brief Profile

Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 5,730 employees worldwide, the Group generated revenue of €2,066.1m in fiscal year 2023/24 (to 30 September).

The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 39 percent of Carl Zeiss Meditec AG's shares are in free float. Approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.

For further information visit: www.zeiss.com/med

 

FAQ

What is the significance of ZEISS CLARUS 700 receiving NMPA approval in China?

The NMPA approval allows ZEISS to market and sell the CLARUS 700 fundus imaging device in China, providing Chinese healthcare providers access to advanced retinal diagnostic technology with ultra-widefield, high-resolution imaging capabilities.

What are the key features of the ZEISS CLARUS 700 imaging system?

The CLARUS 700 features True Color imaging, ultra-widefield coverage (133° single capture, 267° multiple captures), Fluorescein Angiography, live infrared imaging, PrecisionFocus, QuickCompare, and AutoBright technology.

How does the ZEISS CLARUS 700 improve retinal diagnostics?

It provides comprehensive visualization from the macula to peripheral retina with high-resolution True Color images, enabling detailed assessment of nonperfused retinal areas and supporting precise diagnostic decision-making.

What is the imaging coverage range of the ZEISS CLARUS 700?

The device captures 133 degrees in a single image and can achieve up to 267 degrees coverage with multiple captures, offering extensive retinal visualization.

How does ZEISS CLARUS 700 enhance clinical workflow efficiency?

It features AI-enhanced capture, PrecisionFocus for quick detail viewing, QuickCompare for pathology monitoring, and AutoBright for automated image adjustment, reducing time spent on image manipulation.