Carl Zeiss Meditec AG said the U.S. Food and Drug Administration granted 510(k) clearance for ZEISS CLINIC 360, a cloud and browser-based software platform designed for ophthalmic practices.
The company plans to launch the product in the U.S. in early fall 2026, pending further regulatory steps. ZEISS CLINIC 360 is not approved for human use in the European Union at this time.
The software aggregates diagnostic data from ZEISS imaging devices—including CIRRUS, CLARUS, and HFA—alongside third-party DICOM-enabled equipment and electronic medical records. It provides a unified patient view, trend analysis for conditions such as glaucoma, and color-coded alerts for progression monitoring. A collaborative care feature enables case sharing and report distribution among practitioners.
ZEISS continues to offer ZEISS FORUM, an on-premise alternative for practices that prefer localized data management. The cloud-based model operates on a subscription basis, with monthly or annual payment options available.
Federico Villegas, Head of ZEISS Medical Technology U.S. and President of Carl Zeiss Meditec USA, Inc., said the platform reflects the company’s focus on simplifying workflows while maintaining patient-centered care.
Carl Zeiss Meditec reported fiscal 2024/25 revenue of €2.23 billion and employs 5,784 people globally. Approximately 59% of the company is held by parent firm Carl Zeiss AG.
The software’s integration with diagnostic devices and EMR systems aims to streamline data handling across multiple practice locations without requiring local software installation.
