HistoSonics’ Edison Histotripsy System Receives CE Mark Approval

July 13, 2026—HistoSonics announced that it has received approval in Europe for its Edison system, enabling the commercialization of the company’s histotripsy technology in Europe and other markets that recognize the CE Mark. In the United States, the Edison histotripsy system received FDA de novo clearance in October 2023, noted the company.

According to the company, the Edison system is a noninvasive, image-guided platform using histotripsy for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors.

HistoSonics advised that it plans to initiate a phased commercial rollout of the Edison system in Europe, beginning with select centers of excellence specializing in liver tumor treatment.

The company stated that the CE Mark approval was based, in part, on clinical data from the #HOPE4LIVER pivotal trial. The study demonstrated a 90% local tumor control rate at 12 months across tumor types treated, with a low complication rate. Patients were enrolled across the United States and Europe, including hospitals in Germany, Italy, Spain, and the United Kingdom.

In April 2025, the company announced the publication of the #HOPE4LIVER 12-month data. Timothy J. Ziemlewicz, MD, et al published the findings in Annals of Surgery (2025;282:908-916).

Additional long-term follow-up data are currently being collected to further validate these outcomes in broader real-world use, noted HistoSonics.