When Freedom-Meditech first announced the ClearPath DS-120 as a first-of-its-kind alternative to traditional diabetes testing, venture capital companies flocked and the company made headline news for a potential diagnostic breakthrough. These days, a simple internet search for the ClearPath results in outdated articles, and the absence of any formal website leaves potential customers or those curious without answers. It is in fact strange that Freedom-Meditech would go through all the work with FDA510k clearance and Series A funding to then not produce marketing, or even a hub for support and sales. It is perhaps because no one bought the ClearPath. At a retail price of nearly $27,000, and without any clear CPT code reimbursement code- perhaps many found it an unworthy investment; we did successfully bill CPT 92235 by the way. It’s too bad that the ClearPath didn’t see more success, because as it would stand years after its first inception, the instrument does detect autofluorescence of the lens very well– caused by the accumulation of advanced glycation endproducts (AGEs). It is thought that the formation of AGEs is accelerated by high blood sugar levels and therefore may be an indicator of diabetes risk. Claims from Freedom-Meditech indicate a one-stop shop for Diabetes diagnosis that can detect diabetes earlier-on than other more traditional diagnostic tools. The research however, isn’t necessary profound nor neither abundant to confirm these claims with certainty. Regardless, the ClearPath does in fact perform autofluorescence of the lens very well and it’s a very simple unit too operate. The operational learning curve couldn’t be simpler– patient alignment is a cinch, the scan takes less than 5 seconds, and results are immediate– even a color coded unit range indicates whether or not to suspect diabetes. Besides the purple plastic hue, and the fact that Freedom-Meditech hasn’t reached sales goals, the ClearPath is more than just an unbillable gimmick- even if the jury is still out.
OUR TAKE: The ClearPath is more than just an unbillable gimmick- even if the jury is still out.
Buzz doesn’t have enough information about this instrument to provide a rating review 🙁
The ClearPath DS-120™ Lens Fluorescence Biomicroscope is cleared by FDA as a tool for the measurement of autofluorescence by scanning the crystalline lens of the eye with a blue light. It is a non-invasive ophthalmic test for the detection of diabetes. 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 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.
The ClearPath DS-120 Lens Fluorescence Biomicroscope is used to detect autofluorescence of the lens, which is caused by the accumulation of advanced glycation end products (AGEs). It is thought that the formation of AGEs is accelerated by high blood sugar levels and therefore may be an indicator of diabetes risk. During a quick scan of the patient’s eye, ClearPath DS-120® quantifies this autofluorescence by rapidly measuring its intensity and also the scattering of light in the lens. The test can be carried out in primary health care.
ClearPath DS-120 can also be used for periodic monitoring of the AGE levels (once every year or every other year, depending on the AGE levels) as it provides a measure of the patients’ long-term metabolic state. Currently, long-term diabetes control is monitored by measuring the HbA1c levels in the blood. This is usually done yearly and gives an indication of blood glucose levels for the previous six to eight weeks. However, Freedom Meditech claims that ClearPath DS-120® provides a cumulative, non-reversible picture of a patient’s uncontrolled glycaemic levels, and hence provides a more complete picture of the historic levels of control.