Newronika αDBS Receives CE Mark for Adaptive DBS System
Newronika S.p.A., a Milan-headquartered medical technology company specializing in advanced deep brain stimulation (DBS), has secured CE Mark certification for the newest commercial version of its αDBS adaptive DBS system. The updated platform now features complete integration with WebBioBank, the company's proprietary cloud-based platform for neural data management.
The certification represents a significant regulatory achievement, making αDBS the first adaptive DBS system approved to continuously monitor neural activity, automatically tailor stimulation based on each patient's therapy settings, and securely transmit this information to a fully integrated cloud-based neural data platform.
Developed through more than two decades of research and innovation, Newronika's technology is designed to interpret the brain's electrical signals and optimize therapy delivery. The system aims to improve treatment effectiveness while minimizing side effects, reducing the frequency of clinical appointments, and easing the overall care burden for both patients and healthcare professionals.
"This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy, and opens a new era in personalized treatment for patients living with Parkinson's disease and other neurological conditions," said Lorenzo Rossi, PhD, Co-Founder, CEO and CTO of Newronika.
Unlike conventional DBS systems that provide constant stimulation regardless of changes in a patient's neurological state, αDBS® dynamically adapts therapy in real time. Using its patented Adaptive Therapy Stim Engine, the system continuously monitors local field potentials (LFPs), interprets neural activity, and automatically fine-tunes stimulation to help patients remain within their ideal therapeutic range.
The αDBS platform combines an implantable pulse generator (IPG), a physician programming interface, and a patient remote control that supports convenient at-home data collection. Together, these components create a connected care ecosystem in which patient information is transmitted continuously, providing clinicians with long-term data that can help refine treatment strategies over time.
WebBioBank Powers Personalized Neuromodulation
A key feature of the newly certified release is the complete integration of WebBioBank, Newronika's dedicated neural data platform, with the αDBS® implant. The cloud-based system gathers and analyzes neuronal activity alongside clinical information from participating healthcare centers, creating a growing repository of anonymized longitudinal data that expands with each new patient.
Initially developed with funding from the Italian Ministry of Education and validated through peer-reviewed scientific research, WebBioBank has contributed to a deeper understanding of the neurophysiology of deep brain structures, the mechanisms underlying DBS therapy, and the development of next-generation adaptive stimulation algorithms. By providing a common analytical platform for clinicians, researchers, and Newronika, the system supports ongoing advances in personalized neuromodulation treatments.
The platform incorporates a robust de-identification framework designed to safeguard patient privacy while enabling secure data sharing across participating medical centers.
The certification represents a significant regulatory achievement, making αDBS the first adaptive DBS system approved to continuously monitor neural activity, automatically tailor stimulation based on each patient's therapy settings, and securely transmit this information to a fully integrated cloud-based neural data platform.
Developed through more than two decades of research and innovation, Newronika's technology is designed to interpret the brain's electrical signals and optimize therapy delivery. The system aims to improve treatment effectiveness while minimizing side effects, reducing the frequency of clinical appointments, and easing the overall care burden for both patients and healthcare professionals.
"This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy, and opens a new era in personalized treatment for patients living with Parkinson's disease and other neurological conditions," said Lorenzo Rossi, PhD, Co-Founder, CEO and CTO of Newronika.
Unlike conventional DBS systems that provide constant stimulation regardless of changes in a patient's neurological state, αDBS® dynamically adapts therapy in real time. Using its patented Adaptive Therapy Stim Engine, the system continuously monitors local field potentials (LFPs), interprets neural activity, and automatically fine-tunes stimulation to help patients remain within their ideal therapeutic range.
The αDBS platform combines an implantable pulse generator (IPG), a physician programming interface, and a patient remote control that supports convenient at-home data collection. Together, these components create a connected care ecosystem in which patient information is transmitted continuously, providing clinicians with long-term data that can help refine treatment strategies over time.
WebBioBank Powers Personalized Neuromodulation
A key feature of the newly certified release is the complete integration of WebBioBank, Newronika's dedicated neural data platform, with the αDBS® implant. The cloud-based system gathers and analyzes neuronal activity alongside clinical information from participating healthcare centers, creating a growing repository of anonymized longitudinal data that expands with each new patient.
Initially developed with funding from the Italian Ministry of Education and validated through peer-reviewed scientific research, WebBioBank has contributed to a deeper understanding of the neurophysiology of deep brain structures, the mechanisms underlying DBS therapy, and the development of next-generation adaptive stimulation algorithms. By providing a common analytical platform for clinicians, researchers, and Newronika, the system supports ongoing advances in personalized neuromodulation treatments.
The platform incorporates a robust de-identification framework designed to safeguard patient privacy while enabling secure data sharing across participating medical centers.
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