The RightEye LLC has announced today that they received the “Breakthrough Device Designation” from the Food Drug and Administration (FDA). For accurate diagnosis and monitoring of the health and vision complication, the company uses eye-tracking technology. This report was published in BETHESDA on Dec 3, 2019.
For medical devices, the FDA designed the Breakthrough Device Program for the official approvals and market clearance. It helps to provide effective treatment and accurate diagnosis for life-threatening or the complicated debilitating diseases. For the diagnosis of Parkinson’s disease RightEye has gained the first-ever “breakthrough device designation. The diagnosis has been done by measuring the objective eye movements.
RightEye is the award-winning company in tracking eye movements as a biomarker for the diagnosis of many diseases by using eye-tracking technology for developing the innovative health care system. It also involves examining the patients through vision tests that are performed by new procedures and vision training program. Eye q test helps the doctors to estimate and asses the health of the brain, concussions, visual disorder, reading disorder and athletic performance in the patients.
The RightEye provides the evidence-based data values that evaluate the quality of eye movements in patients and give the estimation of treatment success. RightEye customers include hospitals, rehabilitation facilities, nationally recognized optometrists, professional sports systems, emergency rooms, and the U.S. military.
There is no single test available for the detection of Parkinson’s disease. For diagnosis doctors mostly rely on several neurological examinations and tests that are designed to confirm the disease. Misdiagnosis is a real issue during this examination of the health community.
According to George Gitchel, the Director of Clinical Research, Education and Clinical Center (PADRECC) at the Richmond Veterans Affairs Medical Center that I have seen many patients with Parkinson’s disease that are struggling for many years for the accurate diagnosis. During the diagnosis and assessment, nearly 60% of patients with Parkinson’s disease are misdiagnosed at least once during the period of diagnosis.
Out of 3, 1 patient must misdiagnose twice. this number is alarming and is not acceptable in this modern world of technology. RightEye as an award-winning institution for eye health care address this issue and developed a device for the accurate diagnosis and received the FDA Breakthrough Designation for providing objective data to the clinical for the correct diagnosis.
Researchers reveal that persistent ocular tremors are exhibited by the patients of Parkinson’s disease. This prevents the stability of vision during the fixation. RightEye vision system is designed in such a way that it detects the ocular tremors during the oculomotor testing.
This technique not only helps the doctors to diagnose the disease, but it detects the disease at an early stage. This is because ocular tremors are easy to detect and diagnosed before the appearance of the common sign and symptoms.
In October 2018 the RightEye vision system had received the FDA clearance for viewing, recording and analyzing eye movements. This was done in support of detecting the visual track impairments in patients with Parkinson’s disease.
The latest eye-tracking technology gives accurate values in numbers that are helpful for the doctors to disclose or diagnose the abnormalities and deficiencies related to eye movements. These anomalies may be the indications for several neurological and oculomotor complications.
According to the words of Adam Gross, who is co-founder and chief executive officer of the RightEye that on receiving the FDA “Breakthrough device designation”, it is the best opportunity for the RightEye to address the critical conditions of the Parkinson disease in such a way that Company can provide the effective treatments.
By doing the early diagnosis, prevention and intervention we can reduce the annual cost of patients with Parkinson’s disease in America i.e. $52billion. it also improves the quality of life for the patients and slows the progression of the disease.