An AI-powered test for the early detection of dementia has secured FDA Clearance, enabling the pioneering technology to be adopted across the United States and supporting its expansion plans around the world.
In a huge boost to its international aspirations, the CognICA Integrated Cognitive Assessment (ICA), developed by Cognetivity Neurosciences, has been given Class II Exempt Medical Device classification.
The ICA, developed in the UK and in use in both primary and secondary NHS care and private settings, is a five-minute, computerised cognitive assessment, delivered on iPad devices, which can detect early-stage dementia more quickly, efficiently and cost-effectively than previous techniques could ever allow.
In addition to its use in clinical settings, it can also support remote, self-administered testing at scale and is geared towards integration with existing electronic health record (EHR) systems.
The fast-growing ICA has already received European regulatory approval as a CE-marked medical device, and registration with the FDA now grants Cognetivity access to the US healthcare market.
US national healthcare expenditure reached $3.8trillion in 2019 and is estimated to rise to $6.2trillion by 2028.
Alzheimer’s and other dementias make up a substantial proportion of that figure, costing the nation $355 billion in 2021, according to the Alzheimer’s Association. That figure could grow to more than $1.1 trillion by 2050, by which time the number of Americans aged 65 and older living with Alzheimer’s alone is expected to have more-than-doubled to 12.7 million.
As such, there is enormous demand for improvements in the diagnosis and treatment of such conditions.
Dr Sina Habibi, Cognetivity’s CEO, 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 revolutionise 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.”
Cognetivity plans to execute a vigorous business development strategy to achieve US-wide commercial rollout, including the establishment of regional outposts in the coming months.
While FDA registration is critical for US commercial rollout specifically, it also has advantages for Cognetivity’s plans in other parts of the world.
“The benefits of reaching this milestone will extend far beyond the US itself,” Dr Habibi explained.
“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.”
