FDA Grants IDE Approval for Newronika's Novel Adaptive Deep Brain Stimulation System for Parkinson's Disease
• Newronika has received FDA Investigational Device Exemption (IDE) approval to commence a pivotal trial evaluating their adaptive deep brain stimulation system for movement disorders, particularly Parkinson's disease.
• The company's innovative AlphaDBS system utilizes real-time brain signal feedback to deliver personalized stimulation therapy, potentially offering improved outcomes over conventional DBS treatments.
• The upcoming multinational pivotal trial will compare the adaptive system's performance against traditional DBS in advanced Parkinson's disease patients, marking a crucial step toward U.S. regulatory approval.
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