ZEISS CLINIC 360 Receives FDA 510k Clearance
ZEISS Medical Technology has 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.
1Not for human use in the EU.
2For more information, please visit the ZEISS EMR Connector API Specification page.
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.
Source: ZEISS Medical Technology