TearLab provides update on CLIA Waiver categorization application for TearLab Osmolarity System

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced today that it is in receipt of a communication from the U.S. Food and Drug Administration ("FDA") indicating that the data submitted by the Company was not sufficient to gain approval of its CLIA Waiver categorization application for the TearLab™ Osmolarity System.

"While we are evaluating the FDA's letter to determine a clear path towards CLIA waiver, we believe that the success of our recently announced Laboratory Director for Moderate Complexity Program gives us the flexibility and time to consider all of our regulatory options," said Elias Vamvakas, TearLab's Chief Executive Officer.

"With FDA 510(K) approval, Medicare reimbursement and more than 120 doctors having already completed all of the Program steps - 20 of which having received their Lab Director's certifications to-date - we are fully engaged in our U.S. commercialization program," continued Vamvakas. 

Source:

TearLab Corporation

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