Italian medtech company Newronika has secured the CE mark for the latest commercial version of αDBS, its adaptive deep brain stimulation (aDBS) system.
The newly approved system comes with full integration to WebBioBank, Newronika’s proprietary cloud-based platform for neural data.
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The CE mark represents the first regulatory approval in Europe for an aDBS system designed to continuously sense neural activity and automatically adjust stimulation based on patient-specific settings.
The αDBS device transmits this neural data directly into an integrated cloud platform.
The device builds on more than 20 years of research and development. αDBS is intended to interpret brain signals and adapt therapy accordingly.
The company states that this could result in improved outcomes, fewer side effects, and a reduction in clinical visits and burden for patients and clinicians.
Deep brain stimulation is typically used to treat neurological conditions such as Parkinson’s disease. Conventional DBS delivers fixed stimulation regardless of brain state.
Powered by a patented Adaptive Therapy Stim Engine, the αDBS system continuously senses local field potentials in the brain, monitors signals in real time, and adjusts stimulation to keep patients within their targeted therapeutic window.
αDBS consists of an implantable pulse generator, a clinician interface, and a patient remote for at-home data collection.
Together, these elements allow for continuous patient monitoring and data transfer, which may support ongoing therapy adjustments over time.
The full integration of WebBioBank with αDBS is central to the CE mark certification. The platform collects neuronal signals and associated clinical data from participating centres, building a de-identified, longitudinal neural data repository.
WebBioBank originated with support from the Italian Ministry of Education and has contributed to research on deep brain structures, mechanisms of action for DBS, and adaptive DBS algorithm development, as published in peer-reviewed studies.
Newronika affirms that WebBioBank’s de-identification design ensures patient privacy.
In addition to receiving the CE mark, Newronika has an investigational device exemption from the US Food and Drug Administration (FDA) to conduct the ADVENT pivotal trial in the US and EU, aimed at supporting FDA approval of both conventional and adaptive DBS systems for Parkinson’s disease.
In the US, αDBS remains investigational and is not cleared or approved for clinical use.
Newronika co-founder and CEO Lorenzo Rossi said: “This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy, and opens a new era in personalised treatment for patients living with Parkinson’s disease and other neurological conditions.”
In October 2025, the FDA cleared NeurAxis’ percutaneous electrical nerve field stimulation (PENFS) system for treating pain linked with a chronic type of gastrointestinal disorder.
