The FDA has granted 510(k) clearance to market Highmark Interactive’s suite of EQ software modules with a specific approval of the balance testing component.
EQ Brain Performance suite addresses cognitive, visual, and balance performance and is the first functional neurological testing tool that is mobile and game-based to be approved by the FDA, according to a news release on the clearance.
The suite’s gamified tests are used on an ongoing basis which creates a “tremendously rich” view of the neurological functions of the user without additional expensive peripherals like special standing plates or headgear, the release said.
Post-injury assessment using the suite takes approximately 10 minutes and gives immediate results and demonstrates the specific area of brain performance that may have been impacted. These results can help the injured patient understand how their performance has changed which they can then pass along to their physician to help with the diagnosis process, according to the release.
“Highmark is creating an entirely new paradigm to monitor and asses brain function,” says Sanjeev Sharma, MD, co-founder and CEO of Highmark Interactive. “Our platform brings together the powerful engagement of mobile gaming with evidence-based medical research in a manner not yet seen in digital health. For the first time, preventative and diagnostic testing is mobile, affordable and fun, making it truly accessible for everyone.”
The balance component, which was previously approved in May 2019 for CE marking in Europe, combined with the company’s suite of cognitive and visual tests, allows the mobile software to provide quantitative and qualitative metrics as they relate to the patient’s neurological status.
Balance can be affected by a litany of conditions including concussions, physical injury, neurodegenerative diseases, vestibular dysfunction, functional aging, headaches, fatigue, and the ingestion of certain medications and drugs. Clinical studies have shown that EQ Brain Performance showed excellent test-retest reliability and consistently provided quantitative measures of poorer balance performance in patients with neurological conditions that affect balance, the release says.
Frederick Carrick, PhD, Global Clinical Scholar, Harvard Medical School and the Carrick Institute’s Dean of Graduate Education, seemed enthusiastic about the new technology.
“EQ covers all the bases,” Carrick says. “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. 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 EQ Brain Performance’s six modules are designed for specific groups from child to elder care and athletes to heavy industrial workers, the FDA Class II diagnostic tool can be used through their application store, or organizations who can enhance their analysis and group management on the EQ Dashboard. All that is required to test and receive results is an internet connection and a mobile device, like a phone or tablet, according to the release.