TearLab Osmolarity System gets CLIA Waiver from FDA

The FDA has granted a waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the TearLab (NASDAQ:TEAR; TSX:TLB) Osmolarity System. The FDA took the action after reviewing and accepting labeling submitted to it by TearLab. “We believe that, with CLIA Waiver and Medicare reimbursement in place, and with the updated American Academy [...]

CMS approves TearLab’s reconsideration request

The Centers for Medicare and Medicaid Services (CMS) has published instructions for updates to the clinical laboratory fee schedule for 2012, including a revised reimbursement rate for the TearLab (NASDAQ:TEAR; TSX:TLB) Osmolarity Test, effective Jan. 1. The payment code of 83861 that currently applies to the TearLab test for diagnosing Dry Eye Disease will be [...]

TearLab taps social media for dry eye awareness

During the past six months, TearLab (NASDAQ:TEAR;TSX:TLB) has initiated a series of social media campaigns as part of an innovative strategy to increase the awareness of dry eye disease (DED) with both patients and doctors. The program is also designed to demonstrate how its diagnostic test for dry eye can change the paradigm of dry [...]

FDA grants CLIA-waiver for TearLab osmolarity test

The FDA has advised TearLab (NASDAQ:TEAR; TSX:TLB) that based on a supervisory review of the company’s appeal, the agency has granted its petition for a waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the TearLab Osmolarity System. After the company’s submission of labelling acceptable to the agency, the CLIA-waiver will be issued. “This marks [...]

TearLab to present at Piper Jaffray Healthcare Conference

TearLab (NASDAQ:TEAR; TSX:TLB) CEO Elias Vamvakas will present an update on the company’s business at the 23rd annual Piper Jaffray Healthcare Conference in New York this morning. Mr. Vamvakas’ presentation will be webcast live and archived for at least 30 days on the company’s website at www.tearlab.com under the “Webcasts” tab in the Investors section. [...]

Seasoned international eye care professional, Richard Lee, joins TearLab

Richard Lee has been appointed EMEA business development director of TearLab (NASDAQ:TEAR; TSX:TLB) to oversee sales, marketing, operations and customer service activities for Europe, the Middle East and Africa. TearLab Reader Mr. Lee most recently was a consultant, helping develop the market for the TearLab Osmolarity System in the U.K. He also has held EMEA [...]

TearLab launches consumer website for dry eye disease

TearLab (NASDAQ:TEAR; TSX:TLB) has launched “allaboutdryeye.com,” a new consumer website and social media program focused on supporting the company’s Accredited Dry Eye Centers program in North America. Allaboutdryeye.com was designed to help people suffering from dry eye disease (DED) by providing a place for them to share their experiences and ask questions, discover the science [...]

TearLab gets IGel reimbursement in Germany

TearLab (NASDAQ:TEAR; TSX:TLB) has received a unique, new “individual health benefits” or IGel code that applies to its osmolarity test for dry eye disease in Germany, effective immediately. IGel is the self-pay coding system that enables reimbursement for insured individuals. The system runs parallel to the state funding system and allows practitioners greater flexibility in [...]

TearLab U.S. patent expands testing beyond osmolarity

TearLab (NASDAQ:TEAR; TSX:TLB) has been granted a U.S. patent, entitled “Biomarker Normalization,” which gives the company broad and blocking intellectual property regarding the ability to compensate for first order dynamics in the eye, which is fundamental to accurate tear biomarker analysis, whether involving proteins, genes, or small molecules. The patent allows TearLab to build on [...]

COLA to accelerate adoption of TearLab dry eye test

TearLab (NASDAQ:TEAR; TSX:TLB) of San Diego has teamed up with COLA, a non-profit clinical laboratory education, consultation and accreditation organization, to help make the TearLab Osmolarity System for dry eye disease available in the U.S. at the point-of-care. The Centers for Medicare and Medicaid Services began reimbursement for the osmolarity test, effective Jan. 1, 2011, only [...]

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