RightEye Vision System Receives Breakthrough Device Designation from U.S. FDA for Parkinson’s Diseas

RightEye LLC, an award-winning health technology company that uses eye-tracking technology to help diagnose and monitor health and vision issues, today announced that the RightEye Vision System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

The FDA’s 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. 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.