FDA Clearance Granted for Mobile Game-Based Neurologic Assessment of Balance  

  • Balance
  • Neurologic examination

The Food and Drug Administration (FDA) has granted 510(k) clearance to a digital tool for assessing balance (EQ Brain Performance; Highmark Interactive, Toronto, Canada). The tool is mobile software delivered on an internet-connected phone or tablet. No other ancillary equipment (eg, specialized plates to stand on or headgear to wear) is required. Clinical studies have shown test-retest reliability and consistency for providing quantitative measures of poor balance performance in individuals with neurologic conditions. 

Dr. Frederick Carrick, global clinical scholar, Harvard Medical School and the Carrick Institute’s dean of Graduate Education, said, ““EQ covers all the bases. It is mobile, scientifically sound, affordable, covers multiple areas of brain function, and it is enjoyable to use. Whether it is for an individual, an athlete, or a health care professional caring for patients, EQ’s mobile testing and continual collection of relevant clinical data is unlike any platform I have seen.”

The tool evaluates cognitive, visual, and balance performance with 6 modules tailored for specific user groups defined by age, athletic participation, or work in a heavy industry. Evaluations are done on an ongoing basis and post-injury assessment takes only 10 minutes. Results that localize deficits are available immediately.

Because testing is done on an ongoing basis, the results can help an injured individual better understand how their performance has changed so they can provide the information to a healthcare provider.  

“Highmark is creating an entirely new paradigm to monitor and asses brain function. Our platform brings together the powerful engagement of mobile gaming with evidence-based medical research in a manner not yet seen in digital health,” said Dr. Sanjeev Sharma, cofounder and CEO of Highmark Interactive. “For the first time, preventative and diagnostic testing is mobile, affordable and fun, making it truly accessible for everyone.”

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