|By PR Newswire||
|January 10, 2014 08:00 AM EST||
SAN DIEGO, Jan. 10, 2014 /PRNewswire/ -- Freedom Meditech, Inc. today announced that it has completed registration activities required to apply the CE Mark under the European Union (EU) Medical Device Directives (MDD) and has received a Canadian Device Establishment License in Canada for the ClearPath DS-120.
The ClearPath DS-120 is a first-in-class, non-invasive tool designed to quickly and accurately measure autofluorescence through a six second scan of the crystalline lens of the eye. A significant number of independent peer-reviewed studies have suggested that elevated lens autofluorescence may be an early indicator of the presence of diabetes.
The CE mark allows for the sale and distribution of the ClearPath DS-120 in all 27 countries in the EU. Additionally, the Canadian Establishment License allows for the sale and distribution of the ClearPath DS-120 in all Canadian provinces.
"These two regulatory accomplishments represent significant milestones for Freedom Meditech and the worldwide adoption of the ClearPath DS-120 device," said Craig Misrach, CEO of Freedom Meditech. "We believe this creates a large opportunity for diabetes detection in Canada and Europe where pre-diabetes and diabetes are growing health problems."
Commercialization of the ClearPath DS-120 in both Europe and Canada will begin in the first half of 2014.
About ClearPath DS-120™
The ClearPath DS-120™ Lens Fluorescence Biomicroscope is cleared by FDA and has the CE mark and Canadian Device Establishment license 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 glycation 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 health care provider. Unlike some eye exams, the scan does not require dilation. The ClearPath is completely non-invasive and does not require a blood draw to produce a result.
About Freedom Meditech
Freedom Meditech, Inc. is a medical device company focused on the commercialization of novel ophthalmic technologies for the detection of disease and management of patient health. The company's first product, the ClearPath DS-120™, a non-invasive tool for the measurement of autofluorescence in the eye has been cleared by the FDA, and has obtained the CE mark and a Canadian Establishment license. I-SugarX is the company's second product currently in development as a non-invasive ophthalmic glucose monitor that measures glucose levels in the eye for people with diabetes. The company maintains corporate and engineering operations in San Diego, CA with supporting research and development activities throughout the state of Ohio. For more information, visit www.freedom-meditech.com or find us on Twitter, Facebook and LinkedIn.
Freedom Meditech, Inc.
(858) 638-1433 x. 226
SOURCE Freedom Meditech, Inc.
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