FDA Approves Neurological Software Modules

The US Food and Drug Administration (FDA) has cleared Highmark Interactive to market a suite of EQ software modules, with specific approvals for their balance testing component.

The company received 510(k) clearance that will allow them to move forward with the comprehensive suite of testing modules for neurologic assessment and monitoring without expensive peripherals such as special plates and headgear.

The software will allow doctors assess injuries in approximately 10 minutes and provide not only immediate results, but also demonstrates the specific area of brain performance that may be impacted. This will help the injured patient better understand how their performance has changed, while providing information to a health professional to facilitate a 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,” Sanjeev Sharma, MD, Co-Founder and CEO of Highmark Interactive, said in a statement. “For the first time, preventative and diagnostic testing is mobile, affordable and fun, making it truly accessible for everyone.”

The balance component, which received a European CE Mark in May, combined with a suite of cognitive and visual tests, enables the software to provide comprehensive quantitative and qualitiative metrics as they relate to the patient’s neurologic status.

The list of conditions that affect balance include concussions, physical injury, neurodegenerative diseases, vestibular dysfunction, functional aging, headaches, and fatigue.

Studies also show that the brain performance platform provided quantitative measures of poorer balance performance in individuals with neurologic conditions known to impair balance when compared to normal controls.

“EQ covers all the bases. It is mobile, scientifically sound, affordable, covers multiple areas of brain function, and it is enjoyable to use,” Frederick Carrick, PhD, Global Clinical Scholar, Harvard Medical School and the Carrick Institute’s Dean of Graduate Education, said in a statement. “Other platforms may have 1 or 2 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,” he added.