Freedom Meditech has submitted a 510(k) application for regulatory clearance of its medical device that can be used to detect chronic disease.
The company’s ClearPath DS-120 Lens Fluorescence Biomicroscope noninvasively scans the eye to identify patients with signs of degenerative changes in the lens of the eye, according to a statement from San Diego-based Freedom Meditech, which bases its research and development in Cleveland.
The device is superior to other alternatives because it doesn’t require a blood draw, there’s no need for a patient to fast prior to testing, and it doesn’t produce any biohazard waste, according to the company.
“Submitting our 510(k) application for the ClearPath DS-120 represents a significant milestone achievement for the company and our shareholders,” CEO Craig Misrach said in the statement.
If the U.S. Food and Drug Administration clears Freedom Meditech’s application, the company would be free to begin marketing and commercializing the device.
The company says the device can detect biomarkers associated with chronic disease up to seven years prior to the occurrence of complications such as renal failure, blindness, amputation or diabetic retinopathy.
Freedom Meditech’s investors include Cleveland-based venture development nonprofit JumpStart as well as a number of individuals. (Disclosure: JumpStart is an investor in MedCityNews’ parent company MedCity Media.)
The company is also developing a diabetes glucose-monitoring device that acquires information by scanning the eye. The devicecould become an alternative to the “finger prick” method of glucose measurement and monitoring.
A company official didn’t immediately return a call.
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