TearLab Corporation Gets FDA Nod for Home Use of Dry Eye Test

TearLab Corp said U.S. health regulators granted a waiver that allowed for the wider use of its device to diagnose dry eye, sending the medical device maker's shares up as much as 80 percent to their highest in eight months. The U.S. Food and Drug Administration granted a Clinical Laboratory Improvement Amendments (CLlA) waiver to the company's TearLab Osmolarity System, based on a supervisory review. The waiver was granted after the regulator classified the test as "simple," from "moderately complex" earlier, a company spokesman told Reuters by phone.
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