FDA Grants TearLab's (TEAR) Osmolarity System Waiver Categorization
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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 ("FDA") has now granted Waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 for the TearLab 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."
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."
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