Palm Beach, FL 1/24/12 (StreetBeat) -- TearLab Corporation (Nasdaq:TEAR) announced today that, after reviewing and accepting labeling submitted to it by the Company, the U.S. Food and Drug Administration has now granted Waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 for the TearLab(R) Osmolarity System.
Elias Vamvakas, TearLab's Chief Executive Officer, commented, "We believe that, with CLIA Waiver and Medicare reimbursement in place, and with the updated American Academy of Ophthalmology's Preferred Practice Pattern guidelines listing tear osmolarity as a more sensitive method to diagnose Dry Eye Disease, the TearLab Osmolarity test is now well on its way toward being established as a standard of care."
About The TearLab Osmolarity System
The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing and can produce a sample-to-answer result in less than 30 seconds.
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