Newronika Receives CE Mark Approval for AlphaDBS, Advancing Adaptive Deep Brain Stimulation for Parkinson's Disease

Newronika is set to launch AlphaDBS, an advanced adaptive deep brain stimulation (DBS) system for Parkinson’s disease, in select European markets this year following its CE Mark approval. This certification ensures the device meets the European Union’s safety, health, and environmental standards, allowing it to be sold commercially. According to the company, AlphaDBS represents a significant advancement in neuromodulation by automatically adjusting stimulation based on real-time brain activity, optimizing symptom control while reducing side effects. Unlike conventional DBS, which delivers continuous stimulation at fixed settings, AlphaDBS personalizes treatment by responding to patients’ needs dynamically. Newronika also plans to expand globally, with a pivotal clinical trial set to begin in the U.S. The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption, allowing the system to be tested in clinical studies. The CE Mark approval was based on a clinical trial (NCT04547712) comparing AlphaDBS with traditional DBS. Participants underwent both types of stimulation during hospitalization, and some continued treatment at home for a month. The results supported the system’s safety and effectiveness. AlphaDBS features a closed-loop design that records and analyzes brain signals in real time, adjusting stimulation accordingly. The collected brain activity data can be shared via the cloud for remote monitoring by physicians. Newronika aims to set a new standard in Parkinson’s treatment with this innovative technology.