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OcuSense launches point-of-care osmolarity tester
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BERLIN — OcuSense announced the launch of its TearLab Osmolarity System in five European countries here at the European Society of Cataract and Refractive Surgeons meeting.
The company said its "lab-on-a-chip" technology will be available in the United Kingdom, Ireland, Germany, Spain and Italy upon receipt of its CE mark, which company officials told Ocular Surgery News they expect to receive at the end of September.
"Biomarker analysis was an unmet need in ophthalmology," Eric Donsky, chairman and CEO of OcuSense, said.
Mr. Donsky said the point-of-care osmolarity tester uses a disposable microchip that requires 40 nL of liquid to conduct its measurement, running that small amount against osmolarity biomarkers to determine the severity of dry eye.
In a demonstration, the company showed that the device is placed in the tear well, eliminating diluted tears from reflexive tearing. The handpiece is then placed on a docking station that produces the objective measurement.
"The whole workflow takes less than 30 seconds," Mr. Donsky said. "Before the patient even blinks, you're out of the eye."
OcuSense is conducting multiple studies on its own and in conjunction with other companies and will file for 510(k) clearance from the U.S. Food and Drug Administration soon, he said.
"Long-term vision is not just to differentiate diagnosis but to manage the disease" with ongoing monitoring of treatment effect, Mr. Donsky said.