The Food and Drug Administration (FDA) breakthrough device program was designed to streamline the market clearance and approval process for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Oculomotor Test System (RightEye, Bethesda, MD) 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 (PD).
Research has demonstrated that individuals with PD exhibit persistent ocular tremors that prevent stability during fixation. Through oculomotor testing, the Oculomotor Test 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 PD surface.
"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," stated 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. "In my experience Parkinson's patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis. 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."
"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, cofounder 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."
Jennifer Robblee, MD, MSc; Amaal J. Starling, MD; Rashmi B. Halker Singh, MD, FAHS, FAAN; and Nina Riggins, MD, PhD
Chen Zhao, MD; Claire Flaherty, PhD; Paul J. Eslinger, PhD; and Krishnankutty Sathian, MBBS, PhD
Alexis Dallara-Marsh, MD