Plymouth, MN-based ultrasound technology developer HistoSonics has received the CE Mark for its Edison Histotripsy System, allowing commercialization in Europe and other CE Mark-recognizing markets.
The system uses histotripsy, a noninvasive focused ultrasound technology that mechanically destroys liver tumors without surgery, needles, radiation, or heat, according to the company. The system received De Novo clearance from the U.S. Food and Drug Administration (FDA) in 2023 and is backed by clinical data from the multinational HOPE4LIVER trial, which showed a 90% local tumor control rate at 12 months, the firm noted.
HistoSonics plans a phased European rollout beginning with liver tumor centers, targeting patients who are not candidates for surgery or conventional ablation.
