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BRIEF-Tearlab corporation provides update on U.S. regulatory strategy for Tearlab Discovery™ System
October 17, 2017 / 12:13 PM / a month ago

BRIEF-Tearlab corporation provides update on U.S. regulatory strategy for Tearlab Discovery™ System

Oct 17 (Reuters) - Tearlab Corp:

* Tearlab Corporation provides update on U.S. Regulatory strategy for Tearlab Discovery™ System

* Tearlab Corp says it has elected to pursue initial U.S. FDA clearance of a test card measuring a single inflammatory biomarker, MMP-9, in combination with co’s osmolarity test​

* Tearlab - ‍ elected to pursue initial FDA clearance of test card measuring a single inflammatory biomarker, MMP-9, in combination with osmolarity test​

* Tearlab Corp - previously planned to seek clearance of a test card containing a total of two inflammatory biomarkers plus osmolarity to aid in diagnosis and management of dry eye disease​

* Tearlab - ‍believes revised strategy can reduce review period of application since inflammatory biomarker selected, MMP-9, has fda cleared predicate​

* Tearlab Corp - ‍change in regulatory strategy is not expected to impact prior guidance in relation to timing of filing of co’s FDA 510(K) application for clearance of Tearlab Discovery System​

* Tearlab corp says it believes revised strategy can reduce review period of application since inflammatory biomarker selected, MMP-9, has an FDA cleared predicate​

* Tearlab Corp - ‍company remains on track to submit its FDA 510(K) application for Tearlab Discovery System​ by end of 2017 Source text for Eikon: Further company coverage:

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