FDA Neuro Ophthalmology

RightEye Has “Breakthrough” in Its Vision for Parkinson’s Test

There could soon be an eye test to aid in the assessment of Parkinson’s disease. FDA has recently granted breakthrough device designation to a technology designed by RightEye that uses objective eye movement measurements to help detect the neurological disease.

If the RightEye Vision System could gain a nod from FDA for detection, it would be a gamechanger because currently, 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.

“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 a 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.”

The Bethesda, MD-based company’s Vision System has already earned some stripes from FDA. In 2018 the device received clearance from the federal agency 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.

Outside of RightEye’s plan to assess in the detection of the disease, medtech has been making tremendous strides in the treatment of the neurological disorder’s symptoms in recent years.

Global Kinetics Corporation made its mark in Parkinson’s disease by conducting a randomized and controlled study to evaluate the widespread implementation of target ranges derived from its wearable device, the Personal KinetiGraph (PKG). The target ranges could dictate treatment decisions for Parkinson’s. The PKG monitors symptoms of Parkinson’s patients throughout the day. GKC received FDA clearance for the PKG in 2014.

Boston Scientific has also been prominent in the treatment of Parkinson’s disease symptoms. In 2018, the Marlborough, MA-based company released one-year data supports the effectiveness of the Vercise, a deep brain stimulation (DBS) technology for the treatment of advanced levodopa-responsive Parkinson’s disease. Boston Scientific received FDA approval for Vercise in 2017.


Original Article: (https://www.mddionline.com/righteye-has-%E2%80%9Cbreakthrough%E2%80%9D-its-vision-parkinson%E2%80%99s-test)