FDA Clears Potential Cognitive Screening Test Delivered Digitally

The Food and Drug Administration (FDA) granted clearance to market a digitally delivered cognitive assessment (CognICA Integrated Cognitive Assessment; Cognetivity, Vancouver, British Columbia, Canada). 

The digital cognitive assessment is a 5-minute cognitive assessment that includes  artificial intelligence (AI)-assisted visual processing and is delivered to iPad devices. The test features sensitivity to mild cognitive impairment, is inclusive of different cultural or educational backgrounds, and has no repeat test effect. The ICA is geared towards seamless integration with electronic health record (EHR) systems as a self-administered testthat can be administered at scale.

Commenting on the announcement, Dr Sina Habibi, Cognetivity’s chief, said: “We’re delighted to have reached this major company milestone, which is the culmination of many years of hard work. This grants us access to the world’s largest healthcare market, where, sadly, there is much more to be done to tackle the massive problem of dementia. Of course, we’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the US and make a positive impact on the health and wellbeing of millions of Americans.”