@ TearScience Achieves FDA Clearance for Second Generation LipiFlow® Thermal Pulsation System | SEBIO

TearScience Achieves FDA Clearance for Second Generation LipiFlow® Thermal Pulsation System

Posted by on Feb 2, 2012

MORRISVILLE, N.C.,— TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow® Thermal Pulsation System , a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids. The second generation product includes a more robust graphical user interface and provides the ability for physicians to treat both of a patient’s eyes simultaneously.

The new LipiFlow® console incorporates an enhanced graphical user interface by controlling pressure and displaying the treatment temperature, pressure sequence and treatment time remaining. The new LipiFlow® also allows physicians to store a record of the treatment on the device and on electronic medical record servers, eliminating the need to manually document the treatment in patient records.

LipiFlow®’s second generation product also allows physicians to treat two eyes simultaneously. Time savings achieved by performing a bilateral treatment is beneficial for both busy physicians and patients alike.

“We are pleased to have received FDA clearance for the second generation LipiFlow® to offer to our current and future customers,” said Tim Willis, chief executive officer and co-founder of TearScience. “The improvements in this next generation LipiFlow® reflect TearScience’s commitment to innovation. TearScience expects to provide many more enhancements that will assist physicians in treating dry eye sufferers efficiently, effectively and profitably.”

TearScience’s second generation LipiFlow® product will be commercially available in March 2012. Physicians currently using TearScience’s first generation LipiFlow® will be upgraded to the new system.

TearScience sells 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. LipiView® won the 2011 Medical Design Excellence Award.


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