www.fdanews.com/articles/195054-righteyes-parkinsons-diagnostic-gets-breakthrough-status
RightEye’s Parkinson’s Diagnostic Gets Breakthrough Status
December 8, 2019
RightEye received a breakthrough designation from the FDA for the RightEye Vision System, a device that helps assess patients for Parkinson’s disease.
The device records and analyzes data on patient eye movement in search of persistent ocular tremors that are caused by the disease. The data can help doctors both diagnose the disease at an earlier stage, the company said.
“No single test is capable of definitively diagnosing Parkinson’s disease. Doctors instead rely on a variety of neurological examinations designed to confirm the clinical diagnosis,” RightEye said.