Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) Medical Device Regulation (MDR) Class IIa certification.

The certification means the cognitive impairment screening tool is safe, effective and compliant with the governing laws.

CCE aims to give primary care, specialists and researchers an accurate digital cognitive assessment tool that is brief and easy to dispense and brings clarity to early cognitive impairment.

It also combines objective analysis of cognitive performance with qualitative metrics designed to deliver brain health insights and a customized action plan to treat the disease.

"The growth of dementia is a significant public health problem across the world," Dr. Alvaro Pascual-Leone, Linus Health chief medical officer, said in a statement.

"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."

THE LARGER TREND

In October, Brook Health collaborated with Linus Health to allow patients to be screened, assessed and sent home with a treatment strategy for cognitive issues on the same day. 

The marriage of Linus Health's advanced digital cognitive assessment tools with Brook Health's remote care platform aims to empower primary care physicians, making early detection of mild cognitive impairment, a forerunner of dementia, as standard as other preventive screening methods. 

The company made two acquisitions this year. In July, it acquired Together Senior Health, a brain health company for individuals suffering from cognitive decline, and in March, it purchased Aural Analytics, which provides clinical-grade speech analysis. 

In 2022, Linus Health acquired Kinesis Health Technologies, an Irish startup focused on physical-function assessment. A University College Dublin spin-out, Kinesis focuses on digitally assessing gait, balance, mobility, fall risk and frailty. Linus Health said the acquisition will help it expand its scope of services to include both physical and cognitive assessments.