FDA Clears 5-Minute Test for Early Dementia

FDA Clears 5-Minute Test for Early Dementia

The US Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.

Developed by Cognetivity Neurosciences Ltd, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper-based cognitive tests, the company said in a news release.

“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias and absence of learning effect upon repeat testing,” the company notes.

Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.

“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,” Sina Habibi, PhD, co-founder and CEO of Cognetivity, said in the news release.

The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the UK’s National Health Service.

More information is available online.

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