HistoSonics wins CE mark for Edison histotripsy liver tumor system in Europe

PUBT · 1d ago
HistoSonics wins CE mark for Edison histotripsy liver tumor system in Europe
  • Lumira Capital portfolio company HistoSonics received CE Mark for its Edison histotripsy system, opening European commercialization.
  • Edison is a non-invasive, image-guided focused-ultrasound platform intended to mechanically destroy liver tumors, including unresectable tumors.
  • Approval was supported by HOPE4LIVER pivotal-trial data showing 90% local tumor control at 12 months with a low complication rate.
  • HistoSonics plans a phased European rollout starting with select liver tumor centers of excellence.
  • Edison previously received FDA De Novo clearance in October 2023.


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