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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.
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.