Company
510(k) Dry Eye Clearance
U.S. FDA 510(k) clearance for Tixel i® for application of localized heat and pressure for evaporative dry eye due to MGD.
Press release summary
Knoxville, TN — Novoxel announces U.S. FDA 510(k) clearance of Tixel i® (pronounced “Tixel Eye”) for sale in the USA.
Tixel i® is cleared for application of localized heat and pressure for patients with evaporative dry eye due to Meibomian Gland Dysfunction (MGD).
Key points
- A multi-site clinical study demonstrated improvements in objective scores (such as TBUT and MGS) and a reduction in patient-reported symptoms (OSDI).
- Tixel® systems use proprietary Thermo‑Mechanical Action (TMA®) instead of light or laser energy.
- The technology permits treatment of glands in both the upper and lower eyelids to help improve delivery of lubricating oils to the eye surface.
Physician perspective
“Unlike other systems, the procedure is simple: anesthesia is not required, no coupling gel is needed, there are no complicated applicators, and there are no bright flashes of light.”
Local support
For additional information, visit www.Tixel.us/DryEye.
About Novoxel
Established in 2011, Novoxel focuses on scientific and clinical innovation and has been granted numerous patents around the world. The Tixel family of products uses proprietary Thermo‑Mechanical Action (TMA®) to deliver clinical results with non-invasive treatments and minimal downtime.