StoryRegulatory
Newronika wins CE mark for AlphaDBS adaptive deep brain stimulation for Parkinson's
Newronika's AlphaDBS, a closed-loop system that adjusts stimulation from real-time brain signals, received the CE mark. The company says clinical data showed adaptive DBS gave patients more time without symptoms or side effects than conventional DBS, and planned a launch in select European markets in 2025.
- Approval based on safety and effectiveness data; the release gives no figures
- Newronika had recently received an FDA IDE to start a pivotal US trial
- Quoted: Lorenzo Rossi, CTO and co-founder