PD is a chronic, neurodegenerative disease that affects your movement. It tends to be very difficult to diagnose, particularly during early stages, when people experience fewer symptoms. That means the disease is generally far along by the time most people develop noticeable movement and coordination problems.
If healthcare providers had tools for earlier diagnosis, we might better understand how the disease develops, what treatments might be useful, and possibly how to prevent permanent neurological damage and movement disruption.”2
What is the RightEye Vision System?
A medical device designed to detect tiny eye movements, the RightEye Vision System was approved for use by the FDA in October 2018.3 The device is approved to record, view, and analyze eye movements as a way to identify certain visual problems in people with Parkinson’s.
The data collected by this system has helped doctors identify eye movement abnormalities that can be a sign of neurological or eye movement disorders. These include brain injuries and concussions, but they have to potential to identify Parkinson’s, as well.”3
What is the Breakthrough Device Program?
The Breakthrough Device Program is offered by the FDA as a way to speed up the development and review of certain medical devices that might offer more effective treatment or early diagnosis of irreversible or deadly diseases.4 The program allows people with Parkinson’s early access to these devices while they are still being tested. If the new devices are approved by the FDA as being safe and effective, the devices can be sold to the public.5
How do eye movements connect to Parkinson’s disease?
Data shows that people with PD often experience tiny tremors in their eyes. RightEye may be able to detect these tremors, which might help doctors diagnose Parkinson’s disease. Eye tremors are detectable way before other more obvious movement problems develop. So being able to test for them might provide a reliable technique for early diagnosis of Parkinson’s.”3
Benefits of early diagnosis of Parkinson’s disease
There is no single test to diagnose Parkinson’s disease. The disease is generally diagnosed once motor symptoms appear. But by then it has already progressed substantially. Research shows that 60 percent of people with Parkinson’s are misdiagnosed at least once. One-third are misdiagnosed twice.1
“With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson’s disease,” said to Adam Gross, co-founder and CEO of RightEye. “The annual cost of Parkinson’s disease in America is estimated at approximately $52 billion. Earlier assessment, intervention, and more accurate diagnoses, is anticipated to reduce these costs, while also improving patient outcomes and quality of life.”3
Inacio, P. RightEye’s Vision System for Early Diagnosis Named ‘Breakthrough Device’ by FDA. December 4, 2019. Parkinson’s News Today. Available at https://parkinsonsnewstoday.com/2019/12/04/righteyes-vision-system-named-breakthrough-device-fda-early-diagnose-parkinsons/. Accessed 12/20/19.
Viviescas, A. New Diagnostics for PD Might Allow Early Diagnosis, Prevention. Parkinson’s News Today. February 8, 2019. Available at https://parkinsonsnewstoday.com/2019/02/08/new-diagnostic-criteria-in-parkinsons-might-improve-treatment-prevention/. Accessed 12/20/19.
RightEye Vision System Receives Breakthrough Device Designation from U.S. FDA for Parkinson's Disease Test. PR Newswire. December 3, 2019. Available at https://www.prnewswire.com/news-releases/righteye-vision-system-receives-breakthrough-device-designation-from-us-fda-for-parkinsons-disease-test-300967751.html. Accessed 12/20/19.
Breakthrough Devices Program. US Food & Drug Administration. Available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program. Accessed 12/20/19.
Truong, K. FDA finalizes new breakthrough device designation rule. MedCity News. January 1, 2019. Available at https://medcitynews.com/2019/01/fda-finalizes-new-breakthrough-device-designation-rule/. Accessed 12/20/19.