Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform

Highmark Interactive has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its suite of EQ software modules, with specific approval on its innovative balance testing component.
 
Given that EQ’s gamified tests are used on an ongoing basis, there is a tremendously rich understanding of the neurological function of the user. Unlike traditional options for testing to this point, there are no additional expensive peripherals (I.e., special plates to stand on, headgear to apply). The post injury assessment takes approximately ten minutes and provides not only immediate results, but also demonstrates the specific area of brain performance that may be impacted. The immediate results can help the injured individual better understand how their performance has changed and they can provide this information to a health professional for the facilitation of clinical diagnosis.
 
“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, co-founder and CEO of Highmark Interactive. “For the first time, preventative and diagnostic testing is mobile, affordable, and fun, making it truly accessible for everyone.” 
 
Highmark’s balance component, which had already received European CE Mark clearance in May 2019, combined with their suite of cognitive and visual tests, enables their mobile software to provide comprehensive quantitative and qualitative metrics as they relate to an individual’s neurologic status. The list of conditions that could affect balance include concussions, physical injury (musculoskeletal), neurodegenerative diseases (including Parkinson’s and multiple sclerosis), vestibular dysfunction, functional aging, headaches, and fatigue. Additionally, ingestion of certain medications and drugs (including cannabis) can have side effects that impair balance. Clinical studies showed that EQ Brain Performance exhibited excellent test-retest reliability and consistently provided quantitative measures of poorer balance performance in individuals with neurologic conditions that are known to impair balance, compared to normal controls.
 
Highmark Interactive’s gamification of medical evidence-based testing, merged with a completely mobile platform that requires no additional accessories, sets it apart within the industry. It provides an ongoing functional assessment of an individual over time, thus enhancing the ability to detect early warning signs of illness or conditions that might lead to adverse health incidents.
 
EQ Brain Performance’s six product modules are tailored specifically toward user groups, from youth to elder care and from athletes to those working in heavy industry. The FDA Class II medical mobile diagnostic tool can be used by individuals through their app store, or by organizations (e.g., medical professionals, sports teams, schools, employers) who can enhance their analysis and group management on the EQ Dashboard. All that is required for testing and results monitoring is internet connectivity and a mobile device, from anywhere in the world.