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TearLab eye diagnostic rejected by US FDA over lack of data

TearLab Corp. said the U.S. Food and Drug Administration rejected its TearLab Discovery MMP-9 test, which helps diagnose dry eye disease.

The FDA said the data in San Diego-based TearLab's 510(k) submission has not met the criteria for substantial equivalence.

"We will continue working with the FDA to provide additional data for a new MMP-9 submission and remain committed to securing its 510(k) clearance," TearLab CEO Seph Jensen said in a news release.