AnthroTronix Receives FDA Clearance for Brain Health Assessment Tool

The DANA™ mobile medical application receives FDA clearance

Silver Spring, Md. – AnthroTronix (www.atinc.com), a research and development company that designs health technology, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its computerized cognitive test battery known as DANA™. 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.

“We are pleased that DANA™ has sought and received FDA clearance, leading the way for this type of game-­‐changing technology,” said Corinna Lathan, founder and CEO of AnthroTronix. “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.”

DANA™ is a phone or tablet-­‐based app on Android or iOS operating systems and is indicated for use 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 importance of brain health is no longer being overlooked by physicians, patients, or consumers—it is an essential part of an integrated approach to health and well-­‐being.

“With the steady growth of the mHealth movement, technology that has evidence and science-­‐based functionality is critical,” said Duke University Medical Center’s Murali Doraiswamy, M.D., Director of the Neurocognitive Disorders Program and an AnthroTronix Science Advisor. “Mobile assessment tools such as DANA™ offer great promise to support the diagnosis and care of millions of Americans with cognitive disorders.”

DANA™ was initially developed through funding from the U.S. Navy Bureau of Medicine and Surgery and a Rapid Innovation Fund award by the U.S. Army to help evaluate the medical status of deployed military service members. DANA™ has been tested in Afghanistan.

“This landmark announcement brings AnthroTronix to the forefront of the $1.3 billion digital brain health space,” said Alvaro Fernandez, CEO of SharpBrains.com, an independent market research firm tracking health applications of neuroscience. “We expect a growing number of healthcare stakeholders to adopt validated tools such as DANA™ to better track and monitor a patient’s brain health.”

*Editor’s Note: To read the full 510(k) clearance letter visit www.FDA.gov or http://bit.ly/1nqLLDa.

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