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# ‘Breakthrough’ for RightEye Parkinson’s Test
- URL: https://www.fdaweb.com/breakthrough-for-righteye-parkinsons-test/
- Published: 2019-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:55:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145654

FDA has granted RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinson’s Disease. Currently, no single test is capable of definitively diagnosing Parkinson’s disease and physicians 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 company says.

RightEye says that research has demonstrated that patients with Parkinson’s disease have 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,” it says.

The device received [FDA clearance](https://c212.net/c/link/?t=0&l=en&o=2658659-1&h=237819388&u=https%3A%2F%2Frighteye.com%2Frighteye-eye-tracking-system-receives-fda-510k-clearance%2F&a=FDA+clearance&ref=fdaweb.com) 10/2018 for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in patients. “The data provided by this eye-tracking technology has also demonstrated value in helping doctors uncover eye movement deficiencies or anomalies that can be indicators for a variety of oculomotor and neurological issues,” RightEye says.