Cogstate’s digital cognitive testing system Cognigram is now available in the U.S. after Cogstate was notified by the U.S. Food and Drug Administration (FDA) that Cognigram met the requirements of a Class II medical device from the agency’s Center for Devices and Radiological Health.
“After more than fifteen years of intense efforts in supporting academic research and pharmaceutical clinical trials around the world, Cogstate is excited to enter the U.S. market for cognitive assessment on the front lines of clinical practice,” Frank Cheng, president of Cogstate Healthcare, said in a press release.
“We look forward to bringing the proven and widely-published Cognigram technology into the healthcare ecosystem to benefit an exponentially larger pool of patients,” Cheng added.
Supported by standardized and validated analysis methods, the Cognigram system is a digital cognitive test based on a simple card game. With simple yes and no questions, Cognigram can help physicians recognize subtle changes in the cognitive capacity of a person’s brain.
An individual’s cognition can be affected by several illnesses, including Alzheimer’s disease, HIV-related dementia, and Parkinson’s disease, but it can also be caused by several psychological states, such as stress or fatigue.
Early detection of cognitive changes can be important for prompt management of the condition, with resources to the best care possible.
Designed for anyone ages 6 to 99, Cognigram needs to be prescribed by a physician and to be administered by a qualified supervisor at an authorized testing center. It can be used for a single occasion or to assess cognitive changes over time. It can also be used to evaluate changes in cognitive function following a concussion or other injury.
Because the questions are simply focused in the capacity of a person to identify card changes or to test their memory, the test is not affected by language, education, cultural background, or practice.
Cognigram is currently available in Canada, but the company plans to provide immediate access to the system to U.S. hospitals, physician practices, elder care organizations, schools, and sports teams.