Linus Health Earns Medical Device Regulation Certification in the European Union | PR Newswire [Video]

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

, /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 …