FDA Clears Brain Health Assessment App

Megan Brooks

October 17, 2014

The US Food and Drug Administration (FDA) has cleared a computerized cognitive test battery known as DANA, its developer, AnthroTronix, announced today.

DANA is a phone- or tablet-based app for the Android or iOS operating system and can be used as part of the overall clinical assessment of a patient suspected of having cognitive or psychological problems, the company reports.

"DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state," a company news release explains.

"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," Corinna Lathan, founder and CEO of AnthroTronix, said in the release.

DANA includes a battery of cognitive and psychological tests administered and 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 nonprescription medications, and some nutritional supplements, the company says.

"With the steady growth of the mHealth movement, technology that has evidence and science-based functionality is critical," Murali Doraiswamy, MD, director of the Neurocognitive Disorders Program at Duke University Medical Center, Durham, North Carolina, and science advisor to AnthroTronix, said in the news release.

"Mobile assessment tools such as DANA offer great promise to support the diagnosis and care of millions of Americans with cognitive disorders," he added.

The company says DANA was initially developed through funding from the US Navy Bureau of Medicine and Surgery and a Rapid Innovation Fund award by the US Army to help evaluate the medical status of deployed military service members. It's been tested in Afghanistan.


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