Newronika Receives CE Mark for Adaptive Deep Brain Stimulation System
Milan-based Newronika has secured CE Mark approval for its adaptive deep brain stimulation system, αDBS®, enabling commercial use across the European Economic Area.
Newronika S.p.A., a medtech company based in Milan, has received CE Mark certification for the commercial release of its adaptive deep brain stimulation (aDBS) system, αDBS®. The certification includes full integration with the company's WebBioBank™ cloud-based neural data platform.
The CE Mark signifies the first approval for an adaptive DBS system capable of real-time sensing of neural activity and automatic adjustment of stimulation settings. This allows for personalized therapy that adapts to individual patient needs, distinguishing it from conventional systems that provide fixed stimulation.
Integration with WebBioBank™ enables continuous data transmission and analysis, providing clinicians with longitudinal data that can support ongoing therapy optimization. Newronika aims to improve patient outcomes and reduce side effects and the burden on patients and healthcare providers.
The company is also pursuing FDA approval in the United States and is currently conducting the ADVENT pivotal trial across the US and EU to support this regulatory submission.