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Newronika Secures CE Mark for Adaptive Deep Brain Stimulation System

Milan-based medtech firm Newronika has received CE Mark certification for its αDBS® system, marking the first regulatory approval for an adaptive deep brain stimulation technology that continuously monitors neural activity and adjusts stimulation in real time to suit individual patient needs across the European Economic Area.

Newronika Secures CE Mark for Adaptive Deep Brain Stimulation System
Photo: Bio & News

The αDBS® platform represents a significant departure from conventional deep brain stimulation, which typically relies on fixed stimulation levels regardless of a patient's fluctuating brain states throughout the day. By utilizing a patented Adaptive Therapy Stim Engine, the device senses local field potentials and keeps the patient within an optimal therapeutic window. This development is supported by the integration of WebBioBank™, a cloud-based infrastructure that aggregates de-identified neural data to help clinicians refine long-term treatment strategies.

Following two decades of research, this certification allows the company to deploy its connected care model commercially. The system includes an implantable pulse generator, a physician interface, and a patient remote for data collection. While the European market now has access to the technology, the company continues its global expansion efforts through the ADVENT pivotal trial, which holds an Investigational Device Exemption from the U.S. FDA to evaluate the system for Parkinson’s disease treatment.

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