The world’s first certified and clinically validated medical device for early Alzheimer’s disease detection has completed clinical trials and could soon be marketed as a preventive screening tool.

Developed in union by Xlife Sciences AG and saniva diagnostics GmbH, NeuroMex has secured both U.S. Food and Drug Administration clearance and MDR certification. The device is based on motor responsiveness recordings.

“NeuroMex transforms early detection, allowing timely interventions and optimized resource use in healthcare,” saniva diagnostics GmbH Managing Director Jenny Nisser said.

Research has shown that subtle changes in motor responsiveness can indicate early-stage cognitive decline. NeuroMex measures precise movement patterns that correlate with brain function, detecting abnormalities before conventional cognitive tests. NeuroMex is 83.5% accurate in identifying early-stage Alzheimer’s without traditional cognitive tests, enabling rapid, scalable preventive screening. With the device now entering the partnering phase, Xlife Sciences and saniva bigwigs expect it to become a standard component of annual health examinations.

Xlife Sciences CEO Oliver R. Baumann claims NeuroMex “positions Xlife Sciences at the forefront of a multi-billion-dollar market for neurodegenerative diagnostics and preventative care.”

Xlife Sciences is a Swiss company acting as an incubator and accelerator to develop and commercialize promising research projects from universities and other research institutions in the life sciences sector, aiming to provide solutions for unmet medical needs. Xlife Sciences takes carefully selected projects in the technological platforms, biotechnology/ therapies, medical technology, and artificial intelligence/digital health to the next stage of development and participates in their subsequent performance. 

saniva diagnostics GmbH is a medical technology company founded in 2019 and based in Erfurt, Germany. As a spin-off from Jena University Hospital, the company develops and holds the patent for a motor-based testing instrument for early detection of neurodegenerative diseases.