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.

1Not for human use in the EU.

2For more information, please visit the ZEISS EMR Connector API Specification page.

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.

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

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

The Hyper3D world-generation model expands AI 3D generation from individual objects to complete scenes, combining individual 3D assets, spatial relationships and estimated physical properties for robotics simulation, filmmaking, game development and spatial computing.

LOS ANGELES, Sept. 9, 2026 /PRNewswire/ -- Hyper3D, an internationally leading 3D generative AI company, recently announced the launch of WorldGen, a world-generation model that turns a single image into a 3D scene composed of independent, editable and interactive objects. The release expands Hyper3D's generative 3D capabilities from standalone assets to complete scenes that can be used in simulation and creative production workflows.

Users can upload a scene image and let WorldGen identify its main objects automatically, or draw bounding boxes to select specific objects for generation. The generated assets can be edited, replaced and moved individually, giving users control over individual assets and the overall scene layout.

Generating 3D Objects, Spatial Relationships and Physical Properties

WorldGen advances CAST (Component-Aligned 3D Scene Reconstruction from an RGB Image), research developed by the Hyper3D team that received a Best Paper Award at SIGGRAPH 2025, the leading international conference on computer graphics and interactive techniques. Following that research, the team continued developing the models, algorithms and engineering systems that underpin WorldGen's multistage generation process.

The system generates object geometry, inferring plausible shapes for portions hidden from view, and builds a graph of relationships such as contact, support and suspension. It estimates each object's position, scale and orientation in a shared 3D space, along with collision geometry, mass and friction.

WorldGen uses a hybrid 3D representation. Objects intended for editing and interaction are generated by Hyper3D's Rodin model as separate mesh assets with complete geometry and estimated physical properties. Background environments use 3D Gaussian splatting to preserve visual detail and immersion.

From photographs to robot-training environments

For robotics teams, WorldGen turns real-world photographs into simulation training environments for embodied AI. Building such environments has traditionally required manual scene modeling, which is slow and costly; WorldGen generates interactive, physically grounded scenes directly from images, giving robot training a faster way to produce diverse, task-ready simulation data.

WorldGen extends Hyper3D's NVIDIA Isaac Sim workflow from individual assets to entire scenes. Hyper3D, a member of NVIDIA Inception, previously introduced Sim-Ready capabilities for Rodin through NVIDIA Omniverse and Isaac Lab, along with an Isaac Sim plug-in.

In July, Hyper3D announced a joint robotics simulation workflow with D-Robotics and Motphys. In the workflow, WorldGen reconstructs interactive scenes from photographs, while Motphys and D-Robotics contribute physics simulation and computing infrastructure respectively, connecting scene generation, simulation, data collection and model training.

Teams can vary lighting, layouts, obstacles and object states to create different environments for the same task. The workflow spans scene reconstruction, simulation, training and policy validation, including deployment to physical robots for testing and iteration. The partners are continuing to refine the solution and expand its use in robot training.

A controllable 3D foundation for AI filmmaking

For filmmakers, WorldGen provides an editable 3D scene for planning compositions, camera angles and object placement. Creators can set camera angles, move objects, replace assets and adjust layouts, then use rendered views or camera sequences from the scene as visual references for AI video generation.

WorldGen can be used in workflows with video-generation models such as Seedance 2.5. WorldGen supplies stable spatial structure, camera relationships and controllable, untextured 3D scenes; the video model adds character performance, materials, lighting and visual style. The approach is designed to improve control and consistency across complex scenes and multiple shots, supporting advertising, concept films and previsualization. Projects using WorldGen are already in production, with releases to follow.

Bringing Generated 3D Assets into Creative Tools and Game Engines

3D assets generated in WorldGen can be brought into Blender, Unity, PlayCanvas, Unreal Engine and Unity's Tuanjie Engine for material editing, rigging, level design and performance optimization. Users can generate their starting scene assets in WorldGen, then continue working in familiar software and production pipelines.

In July, Hyper3D and Unity's Tuanjie Engine announced a collaboration to connect 3D generation with real-time game applications. WorldGen was also demonstrated at the Tuanjie Engine 2.0 launch.

Extending generated scenes into XR

WorldGen-generated scenes can also serve as the basis for experiences on XR devices such as Apple Vision Pro. Users can explore a reconstructed space from different positions and viewpoints and inspect objects up close. Further editing can support changes to layouts, object replacements and interactions with selected assets. Potential applications include interior design, immersive education, spatial presentations and XR content creation.

About Hyper3D

Hyper3D develops generative AI models and tools for creating 3D assets and scenes. Its core products include Hyper3D Rodin for individual 3D assets and WorldGen for scene-level generation, serving nearly ten million users worldwide. Hyper3D supports workflows across gaming, film production, industrial design, embodied AI and more.

Learn more about Hyper3D at https://hyper3d.ai/

 

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Hyper3D Launches WorldGen to Turn Single Images into Editable 3D Scenes