Last week the FDA granted 510(k) clearance to a mobile-based cognitive test called DANA (Defense Automated Neurobehavioral Assessment), which helps healthcare providers better assess the medical or psychological state of their patients. DANA was developed by Silver Spring, Maryland-based AnthroTronix, a digital health R&D company, and it was developed partially thanks to funding from the US Navy Bureau of Medicine and Surgery as well as a Rapid Innovation Fund award from the US Army. The latter led to DANA being used to help evaluate the medical status of deployed military service members in Afghanistan.
“We are pleased that DANA has sought and received FDA clearance, leading the way for this type of game-changing technology,” Corinna Lathan, founder and CEO of AnthroTronix, said in a statement. “In essence, measuring reaction time is like taking the temperature of the brain—like a "Brain Thermometer"—and it is a vital part of the data that a health professional needs to evaluate their patient.”
AnthroTronix describes DANA as a phone or tablet-based app, available for both Android and iOS, that is used as "part of any clinical assessment where concerns for changes in cognitive or psychological status are present. DANA’s battery of cognitive and psychological tests are administered and the results are evaluated by a qualified health professional who can assess factors that may affect measurement of reaction time such as concussion, dementia, post-traumatic stress, depression, stress, fatigue, prescription and non-prescription medications, and some nutritional supplements, among others," the company wrote in a statement.
In an email to MobiHealthNews last year, an AnthroTronix spokesperson said the program tests the reaction time, memory, and spatial processing of the patient. While the app will likely be useful to the military, the company believes it could also be an important tool for sports medicine. According to its website, AnthroTronix and its partners are currently testing DANA in clinical settings.
The company submitted its app for FDA clearance in July, according to the FDA's database, and received clearance about three months later.
In an effort to commercialize its technology in the past, AnthroTronix has spun out companies. For example, it created a company called AT KidSystems to bring two of its educational products to market.