
Newronika's AlphaDBS Receives European CE Mark for Adaptive Deep Brain Stimulation in Parkinson's Disease
Shots:
- Newronika has reported European CE Mark approval for its AlphaDBS device for Parkinson's Disease following the grant of the US FDA’s IDE approval; commercially available in select EU countries in 2025
- Approval was based on clinical evidence showing longer symptom-free periods compared to traditional DBS, with benefits observed across safety, quality of life, & higher pts preference for adaptive stimulation
- AlphaDBS monitors brain activity & auto-adjusts stimulation based on real-time neurophysiological feedback, allowing enhanced symptom control, reduced side effects, & limited need for adjustments by neurologists
Ref: Prnewswire | Image: Newronika
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