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FDA Gives 510k Clearance to EyeKor’s EXCELSIOR™ Cloud-based Image Management Software for Ophthalmic Clinical Trials
Date:5/3/2013

DAVIS, CA and MADISON, WI (PRWEB) May 03, 2013

EyeKor, LLC, a new service provider dedicated to the support of ocular clinical trials, announces FDA 510k clearance of its EXCELSIOR™ image management software as a class 2 medical device, with indications for use specifically for managing ophthalmic clinical trial data. A first-of-its kind web application, EXCELSIOR™ employs a unique cloud-based architecture to enhance efficiency and accuracy in the collection and interpretation of data from ophthalmic clinical trials. EXCELSIOR™ provides a framework in which images from multiple imaging modalities can be reviewed and analyzed concurrently.

According to EyeKor CEO Christopher J. Murphy, DVM, PhD, “EXCELSIOR™ is unique: No other software leverages data from such a wide variety of ophthalmic instruments while providing such a transparent workflow and ease of access.”

Murphy continues: “EyeKor’s unique relationships with nationally recognized reading centers position it to support EXCELSIOR™ by harnessing the expertise of multiple reading centers with a broad range of functionalities.” These include fundus imaging, corneal imaging, visual field assessment, and electrophysiology—all of which can be viewed and assessed from within the unified EXCELSIOR™ platform.

EXCELSIOR™ provides investigators, clinical trial sponsors, and data managers secure, real-time access to their data and lets them follow its progress through each workflow stage—collection, quality analysis, grading, and interpretation—through a browser interface. The platform is supported by Reading Center trained staff and technicians, who provide certification, clinical site support, and quality analysis of the images—with all analysis and grading harmonized by the EXCELSIOR™ custom viewer that features image-enhancement tools specifically configured for ease of use.

From acquisition to final analysis, EXCELSIOR™ is uniquely designed to mee
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