ZEISS CLINIC 360 receives FDA 510k clearance, amplifying patient care through simplified clinical insights

The ZEISS CLINIC 360 all-in-one browser-based software solution aggregates clinical data at scale and powers advanced analytics for streamlined ophthalmic workflows, providing clinicians with more time for personalizing patient care.

JENA, Germany, Aug. 19, 2026 /PRNewswire/ -- ZEISS Medical Technology, one of the world's leading medical technology companies, today announced the 510k clearance from the U.S. Food and Drug Administration (FDA) for ZEISS CLINIC 360¹. An all-in-one cloud and browser-based software solution, ZEISS CLINIC 360 combines diagnostic and medical data into a comprehensive patient view. By making relevant information easy to access and review, the solution helps clinicians evaluate disease progression, support treatment decisions, and improve workflow efficiency. ZEISS CLINIC 360 is part of the ZEISS ophthalmic workflow portfolio and will be available in the U.S. in early Fall 2026.

"Our strategic focus on digitally connected workflows, combined with the increasing adoption of digital ophthalmic tools in the U.S., has firmly positioned ZEISS at the forefront of empowering ophthalmologists. As ophthalmology continues to adopt connected technologies, clinicians need solutions that fit seamlessly into how their practice operates," says Federico Villegas, Head of ZEISS Medical Technology U.S. and President of Carl Zeiss Meditec USA, Inc. "ZEISS CLINIC 360 reflects our commitment to reducing complexity across the care journey and helping practitioners work more efficiently while maintaining focus on their patients, marking a significant advancement toward the delivery of more personalized patient care."

"Practices are dealing with increasing volumes of information from imaging devices, medical records, and diagnostic testing. With ZEISS CLINIC 360, our game-changing, cloud-based solution presents a truly comprehensive view of a patient, supporting a wide range of practices with actionable clinical insights and flexible configurations," says Anuj Kalra, Head of Chronic Disease Management at ZEISS Medical Technology. "ZEISS CLINIC 360 represents a new standard in patient care support, helping clinicians identify meaningful change more quickly and spend less time searching for what they need."

With the introduction of ZEISS CLINIC 360, ZEISS now offers eye care providers the flexibility to choose the data management approach that best fits their needs. While ZEISS FORUM continues to provide robust on-premise data management for practices that prefer local infrastructure, ZEISS CLINIC 360 delivers a cloud-based alternative that provides flexibility and scalability in a subscription-based model with low upfront costs and predictable monthly or annual payments.

Create a comprehensive patient overview

Combining information from diagnostic devices, electronic medical records, and practice systems, ZEISS CLINIC 360 creates a comprehensive patient record that allows clinicians to view their DICOM-enabled diagnostic device data – including CIRRUS^®, CLARUS^® and HFA^® from ZEISS, as well as third-party devices – to gain a unified, multi-modality view, enabling faster, more informed decisions to deliver high-quality, personalized care. ZEISS CLINIC 360 includes EMR integration² that seamlessly consolidates critical patient data – including risk factors, family history, allergies, and more – into the clinical workflow, organizing medical and diagnostic data together to present a comprehensive view of the patient's condition.

Gain actionable clinical insights 

Leveraging disease-based summaries, interactive analysis, and collaboration tools, ZEISS CLINIC 360 transforms data into actionable clinical insights to enhance patient care. Clinicians can quickly monitor glaucoma progression, for example, with intuitive color-coded alerts and trend analysis of OCT, IOP and Visual Field data. ZEISS CLINIC 360 streamlines the clinical workflow with automated, interactive tools and analyses, providing greater efficiency across the workflow. When consultation is needed, clinicians can securely share cases and reports and request input from colleagues through integrated access to the ZEISS Collaborative Care feature, helping to facilitate improved patient care and referrals.

Designed for different clinical practice models

Built on the ZEISS Health Data Platform, ZEISS CLINIC 360 is accessed through the cloud or a web-based browser, enabling clinicians to review information across locations without requiring local software installation. Subscription options allow practices to select the configuration that best aligns with their operational and clinical requirements.

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

Company Profile

Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the TecDAX and SDAX 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 5,784 employees worldwide, the Group generated revenue of €2,228m in fiscal year 2024/25 (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