Cognetivity’s Integrated Cognitive Assessment Device Completes US FDA Registration


After being granted FDA clearance, the medical device is approved for commercial distribution in the US for cognitive assessments in dementia studies.

Sina Habibi, PhD, CEO, Cognetivity

Sina Habibi, PhD

The Cognetivity Neurosciences Integrated Cognitive Assessment (CognICA) has met the requirements of regulations 21 CFR 882.1470; Class II Exempt Medical Device, following review by the FDA, and after Cognetivity received confirmation on its 510(k) submission last month, it is now permitted to market the medical device for commercial distribution in the US. 

Delivered via iPad devices, the CognICA is a computerized cognitive assessment for studies into dementias, taking patients approximately 5 minutes to complete. The system is artificial intelligence-powered, offering benefit in comparison to traditional pen-and-paper tests that require administration by a health care professional. The device has a high sensitivity to early-stage cognitive impairment and also avoids cultural and educational bias and shows an absence of learning effect when administering repeat testing. The device will integrate with existing electronic health records systems, as testing is able to be remotely self-administered at scale.

“We’re delighted to have reached this major company milestone, which is the culmination of many years of hard work,” Sina Habibi, PhD, CEO, Cognetivity, said in a statement.1 “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.”

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The ICA device was previously granted regulatory approval in Europe, marketed as a CE-marked medical device. In the UK’s National Health Service, the device has been integrated into both primary and specialist clinical care. FDA registration in the US also affords opportunity in different parts of the world, according to Habibi. 

“The benefits of reaching this milestone will extend far beyond the US itself,” Habibi said in a statement.1 “The FDA is the global exemplar in medical regulation; its name carries great weight all over the world. Without a doubt, this mark of certification will bolster our regulatory and commercial efforts in other international jurisdictions as we continue to pursue our ambitions for deployment on a truly global scale.”

The test is a computerized rapid visual categorization task, which displays images for a fraction of a second, asking participants to classify each as an animal or nonanimal. The decision to use animals was based on the strong reaction to animal stimuli in humans, with the brain able to process images of animals in less than 0.2 seconds. 

A 2021 study of the tool included 230 participants who completed the ICA test, including healthy participants (n = 95), patients with mild cognitive impairment (MCI) (n = 80), and patients with mild Alzheimer disease (AD) (n = 55), with investigators then comparing results with several routinely used pen-and-paper tests, including Addenbrooke’s Cognitive Examination (ACE) and the Montreal Cognitive Assessment (MoCA). Investigators found ICA had convergent validity with both MoCA (Pearson r = .58; P <.0001) and ACE (r = 0.62; P <.0001). The ICA model was also able to detect cognitive impairment in patients with MCI with an area under the curve (AUC) of 81%, as well as in patients with mild AD with an AUC of 88%. Significant correlations were observed when assessing education years, with a considerably smaller ICA correlation of 0.17 (P = .01), compared to the MoCA (r = 0.24; P <.0001) and ACE (r = 0.41; P <.0001).2

1. Cognetivity Neurosciences granted FDA clearance for commercial distribution of ICA throughout US healthcare market. News release. Cognetivity Neurosciences. October 20, 2021. Accessed December 1, 2021.
2. Kalafati C, Modarres MH, Apostolou P, et al. Validity and cultural generalizability of a 5-minute AI-based, computerized cognitive assessment in mild cognitive impairment and Alzheimer’s dementia. Front Psychiatry. Published online July 22, 2021. doi:10.3389/fpsyt.2021.706695/full
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