TearLab Gets FDA 510(k) Approval

TearLab Corporation has received FDA 510(k) clearance of its TearLab Osmolarity System. The device is a lab-on-a-chip that both collects and analyzes tears for specific biomarkers to aid in the diagnosis of Dry Eye Disease (DED), a progressive condition that afflicts approximately 40 million people in the U.S. The TearLab System uses a small sample (less than 50 nanoliters) of tears and can produce a sample-to-answer result in less than 30 seconds. The 510(k) clearance allows the company to begin marketing the TearLab system to a limited group of U.S. clinical facilities. According to TearLab CEO Eric Donsky, the market for DED products is growing rapidly, with over 20 novel therapeutic compounds being developed to treat DED.

Related link: Profile of TearLab Corporation

Related video: Eric Donsky, CEO of TearLab Corporation

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