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TearLab

FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence

October 12, 2018 By Fink Densford

TearLab

TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: TearLab

FDA requests more info for TearLab’s eye diagnostic tech

April 11, 2018 By Sarah Faulkner

TearLab

TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears. The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence. The company […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance, Wall Street Beat Tagged With: TearLab

TearLab cuts headcount in restructuring effort

December 22, 2017 By Sarah Faulkner

TearLab

TearLab Corp. (OTC:TEAR) is looking to keep its customer base and reduce the company’s cash burn rate with a new business model that will result in people losing their jobs, according to regulatory filings. The company said that it wants to focus resources on the development of its next-gen TearLab Discovery platform. TearLab did not report […]

Filed Under: Diagnostics, Featured, Optical/Ophthalmic, Wall Street Beat Tagged With: TearLab

TearLab readies for reverse split

February 28, 2017 By Sarah Faulkner

TearLab

Shares in TearLab Corp. (NSDQ:TEAR) said last week that its board approved a 1-for-1o reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month. The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 […]

Filed Under: Diagnostics, Featured, Optical/Ophthalmic, Wall Street Beat Tagged With: TearLab

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