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FDA approves noninvasive ocular test from Freedom Meditech
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ATLANTA – Company executives announced here at SECO that Freedom Meditech has received approval from the U.S. Food and Drug Administration to market the ClearPath DS-120 Lens Fluorescence Biomicroscope.
According to a company press release, the company’s first product is a tool for measuring autofluorescence by scanning the crystalline lens with blue light. Studies have shown that elevated autofluorescence measurements have been linked to high levels of advanced glycosylated end products that accumulate as a result of the aging process and the presence of systemic disease, the release said.
The test is noninvasive, takes 6 seconds to perform and provides “an immediate, quantitative result to the patient and health care provider,” according to Freedom Meditech.
“We are in the process of conducting additional validation studies that 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,” Freedom Meditech Chairman and Chief Executive Officer Craig Misrach said in the press release.
The company reported that it is also developing I-SugarX, a noninvasive monitor that measures the glucose levels in the aqueous of the eye and may serve as an alternative to the finger-stick method of glucose monitoring.