San Diego-based Freedom Meditech Inc., a developer of non-invasive ophthalmic products for the detection of disease and management of patient health, has received 510(k) clearance from the U.S. Food and Drug Administration to market and sell its first product, the ClearPath DS-120 Lens Fluorescence Biomicroscope.
ClearPath is cleared by FDA as a tool for the measurement of autofluorescence by scanning the crystalline lens of the eye with a blue light. In independent scientific studies published in peer-reviewed journals, elevated autofluorescence measurements have been linked to high levels of advanced glycosylated end products, which accumulate as a result of the aging process and the presence of systemic disease.
The ClearPath scan is pain free, takes just six seconds and produces an immediate, quantitative result available to the patient and health care provider. Unlike some eye exams, the scan does not require dilation or other special preparation by the patient. The ClearPath is also different from diagnostic tests in that it is completely non-invasive and does not require a blood draw to produce a result.
The company plans to launch the ClearPath in the United States by the end of the second quarter 2013. Also, the company is in the process of acquiring the CE Mark for the product. The CE Mark is required to sell in the 27 countries that comprise the European Union and is a gateway to other non-regulated markets.
In clinical trial results submitted to the FDA the ClearPath proved to be more precise than standard-of-care ophthalmic devices marketed and widely utilized by health care providers in the United States today. The ClearPath demonstrated a Repeatability Coefficient of Variation (variability among measurements taken on the same eye using the same operator and device) and Reproducibility Coefficient of Variation (variability among measurements taken on the same eye using different operators and devices) of 5.8 percent and 6.4 percent, respectively.
Freedom Meditech also is developing the I-SugarX non-invasive monitor that measures glucose levels in the aqueous of the eye. The I-SugarX is designed to be operated by holding the small handheld device, similar to a miniature telescope, in front of the eye to provide people with diabetes a convenient and pain-free alternative to the "finger stick" method of glucose monitoring.