JUN 26, 2013
Freedom Meditech, Inc. is now selling the ClearPath DS-120 Lens Fluorescence Biomicroscope for routine, non-invasive clinical measurement of lens autofluorescence and light scattering.The company is also pursuing European approval.
Approved by the FDA in January, the ClearPath focuses a beam of light from a blue light-emitting diode on the lens and measures fluorescent green light and blue scattered light using a sensitive silicon photomultiplier. The system includes a target fixation light and a video camera for alignment and automatic pupil tracking. "
With over 100 million eye exams now performed in the U.S. annually, the eye-care provider is a gatekeeper for people within the age range when adult onset diabetes typically presents," explained Craig Misrach, Chairman and CEO of Freedom Meditech. "The ClearPath DS-120 has the potential to change the standard optometry visit and increase the role of the optometrist in the management of their patients' overall health."
Clinical trial results submitted to the FDA showed the device to be more precise than current standard-of-care ophthalmic devices in the U.S, with a repeatability and reproducibility of 5.8 percent and 6.4 percent, respectively.