TearLab Seeks 510(k) Clearance for TearLab Discovery Platform

January 5, 2018: By Jon Swedien

TearLab announced Jan. 4 it has submitted a 510(k) application to the US FDA for its TearLab Discovery Platform, the company’s next-generation in-vitro diagnostic testing system for ophthalmic disease.

The submission covers the platform and a test card measuring the inflammatory biomarker MMP-9.

The platform will also be capable of performing TearLab’s FDA-cleared tear osmolarity test for dry eye disease, TearLab said.

San Diego-based TearLab recently announced it has a new business model that will focus its commercialization efforts on supporting existing customers, concentrating resources on completing the development of its TearLab Discovery Platform, and reducing its cash burn.

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