Newronika Receives CE Mark for Adaptive Deep Brain Stimulator

Milan-based medtech company Newronika has achieved CE Mark certification for its adaptive deep brain stimulation (αDBS®) system. This regulatory milestone allows for commercial use across the European Economic Area and includes full integration with the company's WebBioBank™ cloud-based neural data platform.

The certification signifies the first approval for an adaptive DBS system capable of continuously sensing neural activity and automatically adjusting stimulation based on patient-specific settings. The collected data is transmitted to an integrated neural data cloud platform.

Developed over two decades of research, the αDBS® system aims to improve patient outcomes by reducing side effects and the frequency of clinical visits. Unlike conventional DBS, which delivers fixed stimulation, αDBS® continuously adapts stimulation to real-time brain signals using its patented Adaptive Therapy Stim Engine.

This CE Mark is a significant step towards potential U.S. Food and Drug Administration (FDA) approval. Newronika is currently conducting the ADVENT pivotal trial across the United States and the European Union to support an FDA clearance for Parkinson's disease treatment.