Zeiss Clinic 360 Ophthalmic Software Solution Wins FDA Nod

ZEISS Medical Technology has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Zeiss Clinic 360, a cloud and browser-based software solution that combines diagnostic and medical data into a comprehensive patient view.

Zeiss Clinic 360 merges diagnostic device data, electronic medical records, and practice systems into a unified patient record. It integrates DICOM-enabled data from ZEISS and third-party devices with clinical information such as risk factors, family history, and allergies to provide a consolidated view within the clinical workflow.

The solution uses disease-based summaries, interactive analysis, and collaboration tools to turn clinical data into actionable insights. For glaucoma, clinicians can track disease progression using color-coded alerts and trends across OCT, IOP, and visual field data. The platform also streamlines workflows and enables secure case sharing and consultations through ZEISS Collaborative Care.

Zeiss Clinic 360 adds a cloud-based, subscription option to the Jena, Germany-based company’s data management portfolio, while Zeiss Forum continues to offer on-premise data management. The cloud platform is designed to provide scalability with lower upfront costs and predictable monthly or annual payments.

Comments from Zeiss execs

Federico Villegas, head of ZEISS Medical Technology U.S. and president of Carl Zeiss Meditec USA Inc.: “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. 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.”

Anuj Kalra, head of Chronic Disease Management at ZEISS Medical Technology: “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. 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.”