FREMONT, Calif., June 4 --Nidek Inc. announced it has submitted a supplemental application to the FDA for approval of a Windows-based operating system and for its newly patented intraoperative eye-tracking device for the EC-5000 scanning beam excimer laser. The Windows operating system and four-beam infrared (IR) eye tracker are key elements of Nidek's NAVEX (Nidek Advanced Vision Excimer Laser) customized ablation system for refractive eye surgery.
The Windows operating system, in use internationally for several years, enhances the utility of current laser functions and will provide a reliable platform for the addition of new laser features as they become available, Nidek said.
Hiroshi Okada, vice president and general manager of Nidek, said, "Our new CCD camera eye-tracker system constantly monitors the position of the patient's undilated pupil and is not affected by instruments passing in and out of the surgical field. The eye tracker's speed and accuracy is ideally suited to Nidek's unique scanning slit technology."