Newronika Receives CE Mark for αDBS Adaptive Deep Brain Stimulation System
Newronika has announced that it has received CE Mark certification for the latest commercial release of its αDBS adaptive deep brain stimulation system. The certification, which follows the company’s initial CE Mark announcement in March 2025, now includes full integration with WebBioBank, Newronika’s proprietary cloud-based neural data platform. The system is now certified for commercial use across the European Economic Area, marking the first approval for an adaptive DBS system that continuously senses neural activity and automatically adjusts stimulation according to patient-specific settings.
Conventional deep brain stimulation delivers fixed stimulation regardless of how a patient’s brain state changes throughout the day. αDBS is designed differently. Powered by a patented Adaptive Therapy Stim Engine, the system continuously senses local field potentials, reading the brain’s signals in real time and adjusting stimulation to keep each patient within their optimal therapeutic window. The system includes an implantable pulse generator, a physician interface, and a patient remote that enables at-home data collection. Together, these components enable a connected care model where patient data is transmitted continuously, and clinicians gain longitudinal data that may support ongoing therapy optimization over time.
Central to this CE Mark release is the full integration of WebBioBank, Newronika’s purpose-built neural data platform, directly connected to the αDBS implant. The platform collects and analyzes neuronal signals integrated with clinical data across participating centers, building a longitudinal, de-identified neural data repository. Originally developed with support from the Italian Ministry of Education and validated through peer-reviewed publications, WebBioBank has been used to uncover the neurophysiological dynamics of deep brain structures, characterize DBS mechanisms of action, and develop new adaptive DBS algorithms. The platform’s de-identification architecture is designed to ensure patient privacy across all participating centers.
Lorenzo Rossi, PhD, Co-Founder, CEO, and CTO of Newronika, said the certification validates the company’s vision of a fully connected, data-driven approach to neuromodulation therapy and opens a new era in personalized treatment for patients living with Parkinson’s disease and other neurological conditions.
Alongside its European CE Mark, Newronika holds an Investigational Device Exemption from the U.S. FDA, enabling the ADVENT pivotal trial spanning the United States and the European Union. The trial is designed to support FDA approval of both conventional DBS and Newronika’s adaptive DBS for the treatment of Parkinson’s disease. In the United States, the device is investigational and limited by federal law to investigational use only. It has not been cleared or approved by the FDA.
