Highmark Interactive Receives FDA 510(k) Clearance for Gamified Neurological Testing Platform

‘EQ BRAIN PERFORMANCE’ is the world’s first FDA-approved functional neurological testing tool to be mobile, game-based, and address cognitive, visual and balance performance

TORONTO, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Highmark Interactive, a leader in digital health, announced today it 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.

Featuring the most comprehensive suite of testing on a mobile platform, Highmark Interactive establishes a new benchmark in neurologic assessment and monitoring. 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 10 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.

“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, 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 the most 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.

Dr. Frederick Carrick, Global Clinical Scholar, Harvard Medical School and the Carrick Institute’s Dean of Graduate Education, was effusive with his praise of Highmark’s innovative product.

“EQ covers all the bases. It is mobile, scientifically sound, affordable, covers multiple areas of brain function, and it is enjoyable to use. Other platforms may have one or two of these attributes, but EQ hits all the marks,” said Dr. Carrick. “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.”

Highmark Interactive continues to revolutionize the functional neurological assessment market. Its unique 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 (smart phone/tablet), from anywhere in the world.

For more information:

John Sternal
Merit Mile


For investors and business inquiries:

Tyler Currie
Vice President, Global Business Development & Marketing


Highmark Interactive

Founded in March 2017, Highmark Interactive was created to change the paradigm of neurological testing and management.  The company vision was to become leaders in digital diagnostics and therapeutics by fusing the engagement of mobile gaming with machine learning. Its core product line, EQ Brain Performance, was launched in January 2019 and is utilized on HIPAA and GDPR-compliant cloud-based technology, offering secure data management.  Learn more at www.highmark.tech