FDA Designates RightEye System that Aids Assessment of Parkinson's With ‘Breakthrough’ Status

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BETHESDA, Md.—RightEye LLC, a health tech company that uses eye-tracking technology to help diagnose and monitor health and vision issues, announced this week that the RightEye Vision System has received “breakthrough” designation from the Food and Drug Administration (FDA). The FDA’s “breakthrough” program was designed to streamline the market clearance and approval process for medical devices or drugs that may provide for more effective treatment or diagnosis of 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 the company’s announcement.

No single test yet 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, the announcement noted.

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, according to RightEye’s announcement.

With the “breakthrough” designation, RightEye has “an opportunity to address a critical unmet need in the fight against Parkinson’s disease,” RightEye co-founder and chief executive Adam Gross said. “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 said.

Separately, the company is exploring the possibility of raising $10 million to $15 million in a Series B round of funding, according to a spokeswoman. In September 2017, VSP Global participated in a RightEye fund-raising round, as VMAIL reported