TearLab Update on 510(k) for U.S. FDA Clearance of Discovery™ MMP-9 Test
TEARLAB CORP (TEAR)
Last tearlab corp earnings: 11/13 04:01 pm
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Source: GlobeNewswire
SAN DIEGO, Oct. 10, 2018 (GLOBE NEWSWIRE) -- TearLab Corporation (OTCQB: TEAR) (“TearLab” or the “Company”), today announced that the U.S. Food and Drug Administration (FDA) has determined that the TearLab Discovery™ MMP-9 test, has not met the criteria for substantial equivalence based upon data and information submitted by TearLab in its 510(k) submission. “We understand the FDA’s position and are encouraged by the clear guidance they have provided. We are working diligently to compile the additional information necessary to achieve a 510(k) clearance,” said Seph Jensen, TearLab’s Chief Executive Officer. “We maintain our belief that TearLab Discovery represents a breakthrough technology capable of providing clinically efficient, cost-effective, point-of-care diagnostic tests. 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.” The TearLab Discovery platform is designed to enable eye
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