FDA clears second-generation dry eye device

Morrisville, NC-TearScience has received FDA clearance for a second-generation version of its proprietary device (LipiFlow Thermal Pulsation System) that treats evaporative dry eye by liquefying and evacuating obstructions in the meibomian glands.

The new device includes a more robust graphic user interface than the first-generation device, provides users the ability to treat both eyes simultaneously, and allows for storage of a record of the treatment on the device and on electronic medical record servers, according to the company.

“We are pleased to have received FDA clearance for the second-generation [thermal pulsation device] to offer to our current and future customers,” said Tim Willis, chief executive officer and co-founder of TearScience. “TearScience expects to provide many more enhancements that will assist physicians in treating dry eye sufferers efficiently, effectively, and profitably.”

The second-generation device will be commercially available in March. According to TearScience, physicians currently using the first-generation device will have their systems upgraded to the new system.

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