Bethesda, Maryland-based RightEye has received a 510(k) clearance from the FDA for its EyeQ eye-tracking technology, which is meant to test and track visual impairment as indications of brain health and other neurological conditions.
With its portable computer, users can perform a host of different vision training games and tests that measure and analyze eye movements and compile reports with visual tracking results, along with potential treatment options.
The device – which retails between $5,000 and $10,000 with an additional annual subscription fee – also recommends personalized exercises which can be performed at home to strengthen areas of weakness.
The company’s software can track the results over time showing changes in metrics, trend lines, graphs and replays of eye movements. These diagnostics can highlight vision or eye problems which can be difficult to spot using traditional methods like eye charts.
Some of the leading applications offered through the EyeQ platform include reading assessments that can reveal issues that may be confused with dyslexia or other learning disorders, sports vision tests to improve coordination and reaction times and brain health tests that can reveal the severity of ocular motor issues associated with conditions like Parkinson’s Disease.
“The RightEye system has been an asset to my practice for its ability to help identify conditions that may have otherwise gone unnoticed,” said Adam Clarin, a practicing optometrist at Clarin Eye Care, said in a statement.
“The FDA clearance adds an extra layer of confidence for my patients and my practice. The quick and easy-to-administer tests, coupled with the objective and quantifiable reports, not only guides my decision on the type of treatment to recommend but also makes it simple to explain issues to patients and parents.”
The company’s customer base includes optometry offices, hospitals, rehab clinics, sports teams and the U.S. military. One major partner has been Major League Baseball, where RightEye’s technology has been used to perform baseline screenings for prospective players.
“We are thrilled to receive clearance from the FDA,” RightEye Co-founder and CEO Adam Gross said in a statement.
“It is the culmination of years of scientific research, product development and hard work that have led us to this critical milestone. RightEye is committed to providing innovative, proven eye-tracking solutions that empower doctors to differentiate and expand their practices while transforming the lives of their patients through improved health and wellness.”
RightEye was founded in 2012 has raised more than $10 million in venture capital funding from investors including global vision insurance company VSP Vision Care.
The startup is one of a host of different companies attacking the same problem. One such competitor is SyncThink, which has mainly used its VR eye-tracking headsets in the athletics space to help identify fatigue or warning signs associated with concussions or brain injuries.
In fact, RightEye used SyncThink’s technology as the predicate device with which it applied for FDA clearance.
Palo Alto, California-based SyncThink, which works with sports teams and college sports programs like the Golden State Warriors and the University of Georgia, has previously been reprimanded by the FDA for promoting its device as a way to detect concussions.
In response, both RightEye and SyncThink have taken pains to underscore that while their devices can record, view and analyze eye movements, they cannot provide a diagnosis or diagnostic recommendations.
Another company currently looking to go beyond those efforts is Oculogica, which has developed eye-tracking technology called EyeBox that is currently in clinical trials to get regulatory approval for its ability to diagnose concussions.
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