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TearScience Thermal Pulsation System wins FDA nod

TearScience has received the US Food and Drug Administration (FDA) approval for its LipiFlow Thermal Pulsation System to treat evaporative dry eye caused by meibomian gland dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film.

TearScience has been awarded FDA approval through a nine-center randomized controlled clinical trial which demonstrated the safety and effectiveness of LipiFlow.

LipiFlow applies directed energy to a patient’s eyelid and takes out MGD obstructions during a 12-minute in-office treatment.

TearScience will sell its LipiFlow and LipiView Ocular Surface Interferometer devices as a system for eye care practices.

The LipiView enables physicians to visualize the eye’s tear film.