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FDA Expedites Review Process of Medical Device That May Help Diagnose Parkinson’s Earlier

As researchers uncover evidence that measuring eye tremors may help diagnose Parkinson’s disease earlier, the U.S. Food and Drug Administration has given the RightEye Vision System the “Breakthrough Device” designation.

That means RightEye’s medical device will undergo a faster review process because it speaks to a major unmet need; expedited approvals could allow clinicians to add RightEye to their Parkinson’s assessment toolbox. In fact, doctors already can use the device for detecting vision disorders, they just can’t yet officially use it to diagnose Parkinson’s disease.

RightEye’s developers hope to reduce the amount of time and the number of evaluations required to diagnose Parkinson’s. RightEye identifies eye tremors, which often are detectable long before other Parkinson’s symptoms arise. The longer Parkinson’s goes untreated, the more debilitating and costly it becomes.

“In my experience, Parkinson’s patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis,” George Gitchel, Ph.D., director of clinical research at the Southeast Parkinson’s Disease Research, Education, and Clinical Center, at the Richmond Veterans Affairs Medical Center, said in a Dec. 3 press release. “By providing quantitative, objective data to assist clinicians, I truly believe that RightEye will play a key role addressing this issue.”

In 2012, the Journal of the American Medical Association Neurology published an article that discussed the link between eye tremors and Parkinson’s disease.

“All patients with [Parkinson’s disease] exhibited persistent ocular tremor that prevented stability during fixation,” the authors wrote. “The pervasiveness and specificity of this feature suggest that modern, precise oculomotor testing could provide a valuable early physiological biomarker for diagnosing [Parkinson’s disease].”

For now, doctors continue to rely on a variety of neurological exams to pin down a Parkinson’s diagnosis. There is no single method of confirming the disease. Adding a medical device such as RightEye to the list of tests, however, could help narrow down the time needed to determine the presence of Parkinson’s.

Not only would earlier detection bring about treatment much sooner, it could help reduce the amount of money families and the U.S. government spend on Parkinson’s disease. A recent study commissioned by the Michael J. Fox Foundation and several of its partners found that Parkinson’s costs $52 billion per year – more than double previous estimates.

“Earlier assessment, intervention and more accurate diagnoses are anticipated to reduce these costs, while also improving patient outcomes and quality of life,” said Adam Gross, co-founder and CEO at RightEye.

If you are concerned that you or a loved one may have Parkinson’s disease, make an appointment to meet with Dr. Marianne De Lima, board-certified neurologist and movement disorders specialist at the Neurology Associates Chandler clinic.

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