Newronika Receives CE Mark for Adaptive Deep Brain Stimulation System

Newronika has received CE Mark certification for its adaptive deep brain stimulation system αDBS, now approved for commercial use across the European Economic Area according to a press release. The system is fully integrated with WebBioBank, Newronika's cloud-based neural data platform.

The αDBS system continuously monitors neural activity and automatically adjusts stimulation based on patient-specific settings. It includes an implantable pulse generator, a physician interface, and a patient remote for at-home data collection. This setup allows patient data to be transmitted directly to clinicians for ongoing therapy adjustments.

WebBioBank collects and analyzes neural signals and clinical data across participating centers, creating a de-identified database to support research and therapy optimization. Developed with support from the Italian Ministry of Education, the platform serves as a central data hub for patients undergoing neuromodulation therapy.

Alongside its European certification, Newronika holds an Investigational Device Exemption from the United States FDA for the ADVENT pivotal trial. The study spans the United States and European Union and is intended to support FDA approval of both conventional and adaptive DBS systems for Parkinson's disease treatment.