Linus Health Earns Medical Device Regulation Certification in the European Union

EU MDR Class IIa certification of Core Cognitive Evaluation™ designates the solution is determined safe, effective, and compliant with laws

BOSTON and DUBLIN, Dec. 16, 2024 /PRNewswire/ -- Linus Health, a digital health company enabling early detection of Alzheimer's and other dementias, announced today that its Core Cognitive Evaluation™ (CCE) solution has earned European Union (EU) Medical Device Regulation (MDR) Class IIa certification, indicating the cognitive impairment screening tool is safe, effective, and compliant with the governing laws.

"The growth of dementia is a significant public health problem across the world," said Linus Health Chief Medical Officer Alvaro Pascual-Leone, MD, PhD. "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."

Linus Health's CCE gives primary care, specialists, and researchers a highly accurate digital cognitive assessment that is brief, easy to administer and brings visibility to early cognitive impairment. It combines objective analysis of cognitive performance with qualitative metrics to deliver brain health insights and a customized action plan to treat the disease.

To learn more about Linus Health's complete platform of cognitive health digital assessments, click here. 

About Linus Health
Linus Health is a Boston-based digital health company focused on transforming brain health for people worldwide. By advancing how we detect and address cognitive and brain disorders – leveraging cutting-edge neuroscience, clinical expertise, and artificial intelligence – our goal is to enable a future where people can live longer, happier and healthier lives with better brain health. Linus Health's digital cognitive assessment platform delivers a proven, practical means of enabling early detection; empowers providers with actionable clinical insights; and supports individuals with personalized action plans. We are proud to partner with leading healthcare delivery organizations, research institutions and life sciences companies to accelerate more proactive intervention and personalized care in brain health. To learn more about our practical solutions for proactive brain health, visit www.linushealth.com or follow us on LinkedIn.

Media Contact
Tara Stultz
Amendola for Linus Health (USA)
+14402259595
[email protected] 

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SOURCE Linus Health