The Food and Drug Administration (FDA) has granted Breakthrough Device designation to the RightEye Vision System, a device that measures and analyzes involuntary eye movements to aid in the assessment of Parkinson disease (PD). In 2018, the FDA granted 510(k) clearance to the portable eye-tracking system to help diagnose and monitor health and vision issues.
Previous research has suggested that persistent ocular tremor could be an early physiological biomarker for diagnosing PD. Using precise eye-tracking technology, the researchers found that all 112 PD patients included in the study had persistent ocular instability while fixating on a target, compared with 2 patients in the age-matched control group (n=60).
“In my experience Parkinson patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis,” said George Gitchel, PhD, researcher at Richmond Veterans Affairs Medical Center. “By providing quantitative, objective data to assist clinicians, I truly believe that RightEye will play a key role in addressing this issue, while its FDA Breakthrough Designation will accelerate availability.”
The FDA’s “Breakthrough” designation is granted to drugs or devices that aid in treating serious or life-threatening conditions, or that show preliminary evidence that the product may provide substantial improvement over available devices and therapies.
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