RightEye’s Vision System for Early Diagnosis Named ‘Breakthrough Device’ by FDA

RightEye’s Vision System, an advanced eye-tracking device that measures eye tremors to help diagnose Parkinson’s disease at early stages, has been designated a breakthrough device by the U.S. Food and Drug Administration.

This FDA designation is given select medical devices or products that aim to more effectively treat or diagnose ” life-threatening or irreversibly debilitating diseases.” It streamlines processes to speed these devices’ development, testing, and agency review for approval, possibly allowing them to reach the market more quickly.

Currently, a Parkinson’s diagnosis relies on the outcomes of several neurological tests, and delays are common before a correct decision is reached.

“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 press release.

“In my experience Parkinson’s patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis,” Gitchel added.

Previous research has found tremors that prevent the eyes from fixing with stability are “pervasive” in people with Parkinson’s, and researchers have suggested that eye tremor be considered in diagnosing the disease.

The RightEye Vision System uses advanced eye-tracking technology to measure eye tremors, which usually develop in patients before other symptoms arise. This means that the device may help to detect Parkinson’s at early stages.

The size of a laptop, the system provides objective and accurate visual screening, generating reports that reflect hundreds of collected metrics.

“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,” Gitchel said.  

The system received FDA clearance  for recording, viewing, and analyzing eye movements to help identify patients with troubled visual tracking in October 2018.

“With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson’s disease,” said Adam Gross, co-founder and CEO at 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,” he added.