Italy-based medical technology firm Newronika has secured CE mark approval for its advanced neuromodulation and adaptive deep brain stimulation (DBS) system, AlphaDBS.
AlphaDBS is a next-generation closed-loop DBS system designed to monitor brain activity and automatically adjust stimulation based on real-time neurophysiological feedback.
Its personalised approach optimises symptom control, reduces side effects, and minimises the need for frequent programming adjustments by neurologists.
The FDA approval allows Newronika to commercialise AlphaDBS in Europe, offering a novel treatment option for patients with Parkinson’s disease and other neurological disorders.
Newronika CTO and co-founder Lorenzo Rossi said: “The CE mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation.
“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.”
DBS is a well-established therapy for managing Parkinson’s disease symptoms and is also prescribed for various neurological disorders, said the medical technology firm.
Traditional DBS devices provide continuous stimulation at fixed settings, but advancements in technology have enhanced the customisation of DBS therapy.
The CE mark approval for AlphaDBS is supported by clinical data showing the safety and effectiveness of AlphaDBS in delivering adaptive deep brain stimulation.
In the clinical studies, Newronika’s adaptive DBS system allowed patients to experience more symptom-free time and fewer side effects compared to conventional DBS.
It resulted in an improved quality of life and a preference for the adaptive stimulation mode.
Newronika plans to launch AlphaDBS in select European markets this year, with plans to expand worldwide.
Also, the Italian company received the US Food and Drug Administration (FDA) approval to conduct an Investigational Device Exemption (IDE) study in the US.
