FDA 510(k) Clearance for Freedom Meditech’s ClearPath DS-120™ Ophthalmic Biomicroscope

In short

Freedom Meditech, Inc., developer of non-invasive ophthalmic products for the detection of disease and management of patient health, has received FDA 510(k) clearance to market and sell its first product, the ClearPath DS-120™ Lens Fluorescence Biomicroscope.

Background

The 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 patent and healthcare 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.

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 U.S. today.

The company says it plans to launch the ClearPath in the U.S. by the end of the second quarter 2013.

Company comments

“Receiving FDA clearance for the ClearPath is the most significant milestone to date for the company and removes the last significant risk in product development prior to marketing,” said Craig Misrach, Chairman and CEO of Freedom Meditech. “We are in the process of conducting additional validation studies which we anticipate will support enhanced claims in the labeling for the ClearPath including its ability to further improve patient outcomes and maximize overall public health.”

Regulatory status

ClearPath does not currently possess CE mark clearance, although this process is underway.

Source: Freedom Meditech, Business Wire