Newronika announces CE mark for AlphaDBS system 


Newronika has announced the CE mark approval for its AlphaDBS system to treat Parkinson’s disease. According to a company press release, Newronika is a spin-off of the world-class neurological research centre Policlinico of Milan and University of Milan in Milan, Italy. 

According to NewronikaAlphaDBS is the first rechargeable deep brain neurostimulation system that can continuously record and interpret bioelectrical neuronal activity in the brain areas where stimulation is delivered. AlphaDBS’s proprietary sensing technology records noise-free local field potentials while electrical stimulation is delivered.  

Additionally, the company states that the AlphaDBS system is also capable of closed-loop stimulation where the current delivered is automatically adjusted for the individual needs of each patient. However, Newronika states this feature is currently under clinical evaluation.  

Newronika also notes that the device collects brain signals critical to developing new treatments using a first-of-its-kind telemonitoring platform between patients and physicians.  

“The ability to collect real-time brainwave information from patients with Parkinson’s disease during electrical stimulation treatment provides clinicians with a unique opportunity to understand the disease process and how effective stimulation is while patients participate in normal activities of life,” said Lorenzo Rossi, co-founder and CEO of Newronika. 

“DBS is an established treatment for Parkinson’s disease but there has been minimal innovation in how to deliver the therapy. The capability of AlphaDBS to collect real-time information from the brain with the potential to close the loop is a major advancement for a personalised therapy, which is only delivered when needed. Such an ‘on demand’ therapy holds the promise of better efficacy and less adverse effects than continuous stimulation,” according to Jens Volkmann, professor and chairman of the department of neurology, University Hospital Würzburg, Würzburg, Germany. 


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