Newronika Gains CE Mark for Adaptive DBS for Parkinson’s

Newronika, a Milan, Italy-based company focused on neuromodulation and adaptive deep brain stimulation (DBS) technology, has gained CE mark approval for its AlphaDBS device.

AlphaDBS is a next-gen closed-loop DBS system that dynamically adjusts stimulation based on real-time brain signals. The new treatment option for patients with Parkinson’s disease and other neurological disorders will become commercially available in select European markets this year.

Conventional DBS devices deliver continuous stimulation at fixed settings. AlphaDBS monitors brain activity and automatically adjusts stimulation levels in response to real-time neurophysiological feedback. The personalized approach, according to Newronika, optimizes control of symptoms while minimizing side effects and the need for frequent programming adjustments.

The approval was based on clinical data showing AlphaDBS’ safety and efficacy in delivering adaptive DBS. Clinical trials have demonstrated that patients experience more time without symptoms or side effects compared to conventional DBS. They also showed improved overall quality of life and greater preference for the adaptive stimulation mode, according to the company.

Newronika also plans to advance global expansion, including a recently revealed investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a pivotal clinical trial in the U.S.

“The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation,” said Lorenzo Rossi, CTO and co-founder of Newronika. “This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson’s disease.”

Last month, Medtronic earned FDA approval of its BrainSense Adaptive deep brain stimulation (aDBS) and its BrainSense Electrode Identifier (EI).