The Dry Eye Zone

Rebecca's Blog

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TearLab FDA status revision

Good news for TearLab - it's been reclassified such that it will be easier for drs. to adopt. Bet that will help with their marketing machine.

TearLab Gets FDA Approval for Wider Use of Eye Test

The FDA granted a Clinical Laboratory Improvement Amendments to TearLab to widen the use of its Osmolarity System, a test for dry eye, according to a Reuter's report.

The change came after the device was reclassified to "simple" instead of "moderately complex". Previously, an eye practice had to obtain CLIA certification through paperwork and a 20-hour CME course to use the device. Company shares were trading up at much as 80 percent after the announcement.
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