Transatlantic Partnership Offers Turnkey Solution for Meeting New European Regulatory Demands for Post-market Outcomes Data

ZURICH, MADISON, WI, and NEW YORK: September 8, 2014 — Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data.

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New Excelsior™ Software from EyeKor Speeds Collection and Grading of Images from Multiple Clinical Trial Sites

Imaging is becoming an ever more critical aspect of ophthalmic clinical trials. To begin with, the number of new imaging modalities available to evaluate ocular structures is exploding. Using imaging to gauge the impact of an intervention on appropriate ocular structures allows trial sponsors and regulatory officials to determine both the efficacy of the intervention and its potential to cause harm. As a measure of both safety and efficacy, imaging has become central to today’s ophthalmic clinical trial process.

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