RightEye announced that the RightEye Vision System has received breakthrough device designation from the FDA for a Parkinson’s Disease Test.
The designation is designed to streamline the market clearance and approval process for certain medical devices that provide for more effective treatment or diagnosis of life- threatening or irreversibly debilitating diseases or conditions. RightEye has received the first and only breakthrough device designation for a device that uses objective eye movement measurements to aid in the assessment of Parkinson’s disease, according to a company news release.
No single test is capable of definitively diagnosing Parkinson’s disease. Doctors instead rely on a variety of neurological examinations designed to confirm the clinical diagnosis, and misdiagnosis remains a continuing issue for the health community.
“When assessing Parkinson’s disease, 60% of patients are misdiagnosed at least once, with one third of patients misdiagnosed twice. That is a terrifying and unacceptable statistic in the age of modern medicine,” George Gitchel, PhD, Director of Clinical Research at the Southeast Parkinson’s Disease Research, Education, and Clinical Center (PADRECC), at the Richmond Veterans Affairs Medical Center, said in a company news release. “In my experience, Parkinson’s patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis. By providing quantitative, objective data to assist clinicians, I truly believe that RightEye will play a key role addressing this issue, while its FDA Breakthrough Designation will accelerate availability.”
Research has demonstrated that patients with Parkinson’s disease exhibit persistent ocular tremors that prevent stability during fixation. Through oculomotor testing, the RightEye Vision System is designed to identify these ocular tremors, which may not only help doctors to diagnose the disease but may also help detect the disease at an earlier stage since ocular tremors are often detectable well before other commonly recognized symptoms of the disease surface.
The RightEye Vision System received FDA clearance in October 2018 for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in patients. The data provided by this eye-tracking technology has also demonstrated value in helping doctors uncover eye movement deficiencies or anomalies that can be indicators for a variety of oculomotor and neurological issues.
“With this FDA breakthrough device designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson’s Disease,” Adam Gross, co-founder and CEO at RightEye, said in the news release. “The annual cost of Parkinson’s disease in America is estimated at approximately $52 billion.3 Earlier assessment, intervention, and more accurate diagnoses is anticipated to reduce these costs, while also improving patient outcomes and quality of life.”