In a recent interaction with MedTech Spectrum, Maxwell Liu, Head of Sales & Services at ZEISS Medical Technology China, shared key perspectives on the National Medical Products Administration (NMPA) approval of the ZEISS CLARUS 700 ultra-widefield imaging system. This approval marks a pivotal milestone in expanding access to high-resolution, true-color retinal imaging across China. Designed to capture up to 200° of the retina in a single image, the CLARUS 700 integrates advanced features such as real-time eye-tracking, multi-modal imaging, and peripheral autofluorescence—supporting comprehensive diagnostics for retinal diseases like diabetic retinopathy and age-related macular degeneration. Liu emphasized that this regulatory clearance strengthens ZEISS’s ability to empower Chinese ophthalmologists with best-in-class tools for earlier detection, better documentation, and improved patient management, reinforcing the company’s commitment to elevating eye care outcomes in one of the world’s largest healthcare markets.
What does the NMPA approval of CLARUS 700 mean for ZEISS' growth strategy in China?
The NMPA approval of the CLARUS 700 further builds the ZEISS portfolio in China with additional imaging features and digital workflow integration. The CLARUS 700 offers seamless integration with ZEISS surgical platforms through FORUM platform integration for supporting retina and glaucoma workflows, providing an end-to-end "screening-to-treatment" solution for ophthalmologists in the China market. It also provides ophthalmologists in China with multi-modal diagnostic capabilities, capturing True-color, Blue and Green FAF, external, infrared + FA imaging to support chronic disease management for conditions like Diabetic Retinopathy and AMD.
How does CLARUS 700 stand out in China’s ophthalmic imaging market?
The CLARUS 700 offers imaging features that set it apart in the China ophthalmic imaging market. The device’s ultra-wide imaging capabilities provide 133° single-shot coverage (267° stitched) vs. traditional 30°–55°, cutting exam time and improving detection of peripheral lesions. The device’s high resolution provides 7.3μm detail clarity (2–3× better than competitors) enabling precise diabetic retinopathy staging. The CLARUS 700 also provides dual-modal diagnostics through simultaneous true-color + FA imaging to support systemic disease management (e.g., hypertension). Additionally, the NMPA-certified AI (Gazepoint) of the CLARUS 700 can benefit elderly patients and those with poor fixation, correcting peripheral deformities and increasing the completion rate and success rate of puzzles.
Were there any key challenges in securing NMPA approval, and how were they addressed?
To secure NMPA approval the ZEISS team prioritized and allocated resources to meet target timelines, proactively collaborated with local test labs to complete FA performance testing ahead of schedule, and strategically classified the AI-driven ONH localization as a process optimization AI function instead of a Class III AI, working with the NMPA to simplify the AI requirement with existing datasets.
How does the Fluorescein Angiography feature in CLARUS 700 contribute to more efficient retinal diagnostics and better vision outcomes for patients in China?
The CLARUS angiography aids in the visualization of vascular structures of the retina and the choroid.
Are there plans for partnerships or training to support its clinical adoption in China?
ZEISS currently has four flagship centers for clinician training, including the Ziamen Eye Hospital. Additionally, ZEISS offers digital tools such as FORUM platform integration for a more unified diagnostics-laser therapy workflow for clinicians.
( chaitrali.gajendragadkar@mmactiv.com )
MedTech Spectrum
www.medtechspectrum.com
