TearLab (NASDAQ: TEAR) shares are up 84% mid-day following news that the company’s commercial version of its TearLab Discovery™ System has met all the applicable provisions of In Vitro Diagnostic Medical Devices Directive 98/79 EC required for CE Marking. Regulatory clearance enables the company the ability to market in the European Union and European Free Trade Association member countries and expands regulatory clearance beyond the previously-cleared discovery device to include the first commercial test card. The company is expected to use this clearance to build a clinical data package in support of a 510(k) submission to the FDA, which is expected in the second half of 2017. “The CE mark for the TearLab Discovery(TM) platform represents a breakthrough in ophthalmic diagnostic technology and will help usher in a new era in eye care that leverages the power of molecular diagnostics at the point of care, which has long been standard of care in other medical specialties to both diagnose diseases and guide treatment,” TearLab CEO Seph Jensen stated in the news release.
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About TearLab Corporation
TearLab Corporation develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. TearLab Corporation’s common shares trade on the NASDAQ Capital Market under the symbol ‘TEAR’ and on the Toronto Stock Exchange under the symbol ‘TLB’. For more information, visit www.tearlab.com.
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