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.