NetworkNewsBreaks – TearLab Corp. (NASDAQ: TEAR) Shares Skyrocket on Regulatory Approval of Commercial TearLab Discovery™ System in EU
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…