Linus Health has secured Class IIa certification for its cognitive impairment screening tool, Core Cognitive Evaluation (CCE), under the European Union’s (EU) revised Medical Device Regulation (MDR).
The US digital health company’s CCE tool uses two measures to gauge early signs of cognitive impairment and evaluate brain health risk factors to assess a person’s risk of developing dementia in the future.
Once completed, the Digital Clock and Recall (DCR) screening test, which includes more than 50 graphomotor metrics to assess early signs of cognitive impairment, provides clinicians with specific, actionable recommendations around diagnostic and therapeutic steps.
The CCE tool’s Life and Health Questionnaire (LHQ) focuses on screening for lifestyle and health factors relevant to dementia assessment and provides three outputs in line with Linus’s healthcare delivery approach.
The first is an estimate of whether an individual may be at risk of developing dementia in future based on modifiable risk factors that can be dealt with at present.
Second is the generation of patient-facing educational materials aimed at empowering individuals to take active steps towards better brain health. Informed by scientific evidence, this component highlights areas that need attention and provides personalised, actionable recommendations an individual can take towards attaining better brain health now and in the future.
Finally, the LHQ provides clinical decision support and recommendations intended to guide clinicians on best practices in cognitive decline and dementia care.
Combined information from the LHQ gives individuals a risk score that estimates their likelihood of developing dementia within the next 12 years.
Linus said the risk estimation was developed by using a data-driven approach and informed by validated instruments including the Lifestyle for Brain Health (LIBRA) and the Cardiovascular Risk factors, Ageing, and Incidence of Dementia (CAIDE) risk scores.
Linus Health CMO Dr Alvaro Pascual-Leone commented: "The growth of dementia is a significant public health problem across the world.
“Earning EU Class IIa MDR certification allows us to expand our offering in the EU beyond assessment to include clinical decision support, which is critical in supporting clinicians to navigate next steps, consider concrete actionable recommendations, and connect patients with the right care and clinical interventions that have been shown to delay or even prevent the onset of dementia due to Alzheimer's disease or other causes."
Alzheimer’s is the most common form of dementia. Nonprofit Alzheimer’s Disease International estimates there were more than 55 million people worldwide living with dementia in 2020 and anticipates this number will almost double every 20 years, reaching 78 million in 2030 and 139 million in 2050.
Several other companies are developing screening tools to assess cognitive decline.
In October 2024, South Korean AI company Neurophet partnered with biopharma AriBio to develop an AI-based platform designed to expedite Alzheimer’s diagnoses.
In September, Darmiyan launched the BrainSee Platform, featuring the US Food and Drug Administration (FDA) approved BrainSee test for Alzheimer’s, which focuses on prognosing amnestic mild cognitive impairment (aMCI) in which memory loss is the primary symptom.
