Breakthrough device designation issued for RightEye’s Parkinson’s assessment system
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The FDA has granted breakthrough device designation to the RightEye Vision System, an oculomotor test to help diagnose Parkinson’s disease, RightEye LLC announced in a press release.
Parkinson’s disease is often misdiagnosed; however, research has shown that ocular tremors that prevent stability during fixation are often exhibited in patients with Parkinson’s. The RightEye Vision System is designed to identify these tremors, helping to diagnose the disease and detect it at an earlier stage, the release said.
“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 release. “The annual cost of Parkinson’s disease in America is estimated at approximately $52 billion. Earlier assessment, intervention and more accurate diagnoses are anticipated to reduce these costs, while also improving patient outcomes and quality of life.”